Original Article
Elevation of Systemic Oxygen Delivery in the Treatment of Critically Ill Patients
N Engl J Med 1994; 330:1717-1722June 16, 1994
- Abstract
Background
Elevation of systemic oxygen delivery and consumption has been associated with an improved outcome in critically ill patients. We conducted a randomized trial to determine whether boosting oxygen delivery by infusing the inotropic agent dobutamine would improve the outcome in a diverse group of such patients.
Methods
On the basis of previously published recommendations, we established the following goals: a cardiac index above 4.5 liters per minute per square meter of body-surface area, oxygen delivery above 600 ml per minute per square meter, and oxygen consumption above 170 ml per minute per square meter. If these goals were not achieved with volume expansion alone, patients were randomly assigned to a treatment or control group. The treatment group received intravenous dobutamine (5 to 200 μg per kilogram of body weight per minute) until all three goals had been achieved. Dobutamine was administered to the control group only if the cardiac index was below 2.8 liters per minute per square meter.
Results
A total of 109 patients were studied. In nine patients the therapeutic goals were achieved with volume expansion alone; all nine patients survived to leave the hospital. Fifty patients were randomly assigned to the treatment group, and 50 to the control group. During treatment, there were no differences between the two groups in mean arterial pressure or oxygen consumption, despite a significantly higher cardiac index and level of oxygen delivery in the treatment group (P<0.05). Although the predicted risk of death during hospitalization was 34 percent for both groups, the in-hospital mortality was lower in the control group (34 percent) than in the treatment group (54 percent) (P = 0.04; 95 percent confidence interval, 0.9 to 39.1 percent).
Conclusions
The use of dobutamine to boost the cardiac index and systemic oxygen delivery failed to improve the outcome in this heterogeneous group of critically ill patients. Contrary to what might have been expected, our results suggest that in some cases aggressive efforts to increase oxygen consumption may have been detrimental. .
Media in This Article
Figure 1
Median Cardiac Index in the Treatment and Control Groups.Figure 2
Median Oxygen Delivery in the Treatment and Control Groups.Article Activity
- Article
Despite improvements in resuscitation and supportive care, one or more vital organs fail in a large proportion of patients with acute, life-threatening illnesses1. It has been proposed that organ damage in critical illness is due to inadequate oxygen delivery, often exacerbated by a level of tissue oxygen extraction that fails to satisfy metabolic demands2. Consequently, some investigators have recommended that in patients at high risk who are undergoing surgery, the cardiac index and the delivery and consumption of oxygen be increased to levels that have previously been identified as the median maximal values in survivors (cardiac index, over 4.5 liters per minute per square meter of body-surface area; oxygen delivery, over 600 ml per minute per square meter; and oxygen consumption, over 170 ml per minute per square meter) to replenish tissue oxygen and prevent organ dysfunction3-5. One study demonstrated a marked reduction in mortality among postoperative patients at high risk who were treated in this way,5 and more recent studies have supported the idea that an elevation of oxygen delivery to levels that some have called “supranormal” improves the outcome in patients with trauma6 and septic shock,7-9 as well as in heterogeneous groups of critically ill patients10.
Some researchers, however, remain skeptical11. Provided volume replacement is optimal, it remains unclear whether achievement of these target values simply indicates an adequate physiologic reserve and therefore a better outcome. Although the prognosis is very good for patients in whom oxygen delivery and consumption reach the target levels in response to intravenous fluids alone or only moderate inotropic support, in a substantial number of patients it proves impossible to increase oxygen consumption despite aggressive inotropic support12. In such patients the outcome is poor,12 and the use of high doses of inotropic agents may be associated with an increased incidence of complications, such as tachyarrhythmias, myocardial ischemia, and maldistribution of tissue blood flow. Furthermore, inotropic support is frequently not started until the patient has been admitted to the intensive care unit, and then it is not clear whether boosting oxygen delivery can improve the outcome.
We carried out a prospective, randomized, controlled study of a heterogeneous group of critically ill patients. The purpose of the study was to examine the effects of treatment intended to increase the cardiac index and oxygen delivery and consumption to the previously reported median values in survivors. Treatment was initiated at the time of admission to intensive care.
Methods
The study was reviewed and approved by the ethics committee of the participating hospitals. The patients were unable to give informed consent because of the severity of their condition. Informed consent was therefore obtained from each patient's closest relative.
Selection and Randomization of Patients
Consecutive patients at high risk who were admitted to the intensive care units at two hospitals over a two-year period were screened for inclusion in the study. For patients undergoing surgery, the criteria for high risk were taken from Shoemaker et al.5. Patients not undergoing surgery who had life-threatening cardiorespiratory illnesses (acute respiratory failure or septic shock) were also included. Patients were excluded if they were less than 16 years of age, pregnant, or undergoing neurosurgery or if they had preexisting cardiac disease or hematologic cancer.
After fluid resuscitation, patients in whom the cardiac index and oxygen consumption and delivery failed to reach the target values (see below) were randomly assigned to the treatment or control group with the use of a table of random numbers.
Classification of Condition
Patients were classified as having the sepsis syndrome or septic shock if they met the criteria described by Bone et al.,13 and the adult respiratory distress syndrome if they met the following criteria: a compatible underlying clinical disorder, an inspired oxygen fraction over 0.4 required to maintain the partial pressure of arterial oxygen at a value over 60 mm Hg, radiologic evidence of diffuse bilateral pulmonary infiltrates, and pulmonary-artery occlusion pressure under 18 mm Hg. Admission diagnoses were classified according to the system of Knaus et al.14.
Management
On admission to the intensive care unit, all patients underwent urinary, peripheral arterial, central venous, and pulmonary arterial catheterization. Dopamine was administered to all patients at a dose of 2 μg per kilogram of body weight per minute. Saturation of arterial blood with oxygen was maintained at a level over 90 percent. Intravenous fluids were administered as necessary to achieve an optimal left atrial filling pressure. (The optimal value was determined by plotting the left ventricular stroke-work index against the pulmonary-artery occlusion pressure, with the optimal filling pressure defined as the pulmonary-artery occlusion pressure at the plateau value for left ventricular stroke work.) Blood, human albumin solution, or synthetic colloids were infused as necessary while the hemoglobin concentration was maintained at a level higher than 10 g per deciliter.
Patients were not assigned to the treatment or control group if all three goals (cardiac index above 4.5 liters per minute per square meter of body-surface area, oxygen delivery above 600 ml per minute per square meter, and oxygen consumption above 170 ml per minute per square meter) were achieved after volume expansion. Patients in whom these goals were not achieved were randomly assigned to either the treatment group or the control group.
In the treatment group dobutamine (5 to 200 μg per kilogram per minute) was administered to increase the cardiac index and oxygen delivery until all three goals had been achieved simultaneously, unless there was sinus tachycardia at a rate over 130 beats per minute, tachyarrhythmia, or electrocardiographic evidence of myocardial ischemia, in which case the dose of dobutamine was immediately decreased or discontinued and then titrated to achieve the highest possible values for the cardiac index and oxygen delivery and consumption. In the control group dobutamine was administered only if the cardiac index was less than 2.8 liters per minute per square meter.
In all groups norepinephrine (0.05 to 20 μg per kilogram per minute) was administered, if required, to maintain the mean arterial pressure at 80 mm Hg while avoiding excessive peripheral vasoconstriction (systemic-vascular-resistance index above 1500 dyn • sec • cm-5 per square meter). In both groups treatment was initiated in the intensive care unit, the aim being to achieve target values as soon as possible after enrollment, and was continued until death or apparent resolution of the acute illness.
Measurements
Cardiac output was measured by thermodilution. Hemoglobin and oxygen saturation were determined with a blood oximeter (Cooximeter 282, Instrumentation Laboratories, Lexington, Mass.). Arterial blood lactate levels were measured by an enzymatic technique (GM7 microstat, Analox Instruments, London). The cardiac index, systemic-vascular-resistance index, left ventricular stroke-work index, and oxygen delivery and consumption were calculated with the use of standard formulas. The oxygen-extraction ratio (a measure of the efficiency of tissue oxygen uptake) was calculated as the difference between arterial and venous oxygen content, divided by the arterial oxygen content.
All measurements were obtained on patients' admission to the study; after optimal volume administration; at 1, 2, 4, 8, 12, 16, 20, and 24 hours; every 6 hours for the next 24 hours; and then at least every 8 hours. Scores for the Acute Physiology and Chronic Health Evaluation (APACHE) II14 and APACHE III15 and for organ failure16 were determined with the use of a specific intensive-care data base (Acubase, Clinical Information Systems, Seattle). The risk of death for each patient was predicted from the APACHE II score with the use of the regression equation and with the diagnostic category weighted according to the system of Knaus et al.14.
Statistical Analysis
Data are presented as medians and ranges or as medians ±the 25th and 75th percentiles of the ranges. The incremental area under the curve was used as a summary statistic for the measurements for each patient17 to compare the cardiac index, oxygen delivery and consumption, oxygen-extraction ratio, lactate concentration, and mean arterial pressure in the treatment and control groups for the 48-hour period after optimal volume expansion. If a patient died or was discharged from the intensive care unit before the end of that period, the last set of values obtained before death or discharge was used. At 48 hours, 7 of the 50 patients in the control group and 10 of the 50 in the treatment group had died or been discharged from intensive care.
Comparisons between groups were performed with the Mann-Whitney U test. Discrete data were analyzed with the chi-square test. Mortality data are presented with 95 percent confidence intervals. Differences were considered significant when the probability that they were due to chance was less than 0.05. All P values are two-sided.
Before starting the study, we calculated that with a power of 80 percent and a significance level of 5 percent, 130 patients would be required in each group to demonstrate a 15-percentage-point reduction in the mortality rate (from the expected rate of 33 percent to 18 percent). An interim analysis of outcome in the hospital was scheduled after randomization of each block of 50 patients. At the second interim analysis, in-unit mortality and in-hospital mortality were unexpectedly higher in the treatment group than in the control group. Moreover, actual mortality was higher than predicted mortality in the treatment group, whereas in the control group actual and predicted mortality were the same. Because our best estimate at the time was that the treatment protocol was diminishing survival and the 95 percent confidence intervals indicated that there was unlikely to be substantial advantage for the patients in the treatment group, we decided to discontinue the study18. The data presented here are for the 100 patients randomly assigned to the treatment or control group before the study was discontinued.
Results
We studied a total of 109 patients (69 men and 40 women). In nine patients the therapeutic goals were achieved with fluid administration alone, and these nine were therefore not randomly assigned to the treatment or control group. A total of 50 patients were randomly assigned to the control group, and 50 to the treatment group. Characteristics of the patients at the time of admission are shown in Table 1Table 1
Characteristics of 109 Critically Ill Patients at the Time of Enrollment in the Study.. There were no significant differences in age, APACHE II or III score, predicted risk of death, or organ-failure score between the control and treatment groups (Table 1 and Table 2Table 2
Outcome Data.).Hemodynamic Data, Oxygen Delivery and Consumption, and Lactate Levels
The 48-hour incremental area under the curve for cardiac index (Figure 1Figure 1
Median Cardiac Index in the Treatment and Control Groups.) and oxygen delivery (Figure 2Figure 2Median Oxygen Delivery in the Treatment and Control Groups.) was significantly higher in the treatment group than in the control group (P<0.001 and P = 0.0012, respectively). In the treatment group, however, the increase in the cardiac index and oxygen delivery was accompanied by a fall in the oxygen-extraction ratio. As a result, the 48-hour incremental area under the curve for the oxygen-extraction ratio was significantly lower in the treatment group than in the control group (P = 0.045), and the difference in oxygen consumption between the two groups was not significant (P = 0.12) (Figure 3Figure 3
Median Oxygen Consumption in the Treatment and Control Groups.). The 48-hour incremental area under the curve for mean arterial pressure and lactate level also did not differ significantly between the two groups (P = 0.42 and P = 0.34, respectively).There was no significant difference in lactate levels (median ±25th and 75th percentile) between the two groups either initially (treatment group, 2.2 ±1.8 and 3.5 mmol per liter; control group, 2.1 ±1.5 and 3.3 mmol per liter; P = 0.69) or at 48 hours (treatment group, 1.7 ±1.23 and 2.5 mmol per liter; control group, 1.5 ±1.1 and 2.1 mmol per liter; P = 0.2). In both groups lactate levels at 48 hours were significantly lower than base-line values (P<0.05).
Use of Inotropic and Vasoactive Agents
Thirty-four patients in the control group and 31 in the treatment group received norepinephrine. The median maximal dose administered in the control group was 0.23 μg per kilogram of body weight per minute (range, 0.05 to 10), which was significantly lower than that administered in the treatment group (1.2 μg per kilogram per minute [range, 0.02 to 16.6]) (P = 0.029).
Twenty-one patients in the control group and all the patients in the treatment group received dobutamine at some time during the study. The median maximal dose administered in the control group was 10 μg per kilogram per minute (range, 2.5 to 200), which was significantly lower than that administered in the treatment group (25 μg per kilogram per minute [range, 2.5 to 200]) (P<0.001). Seventeen patients in the treatment group received 50 μg or more of dobutamine per kilogram per minute at some time during the study.
In 35 of the 50 patients in the treatment group, the three target values were not achieved simultaneously despite inotropic support. The in-hospital mortality in this group was 71 percent (the median predicted risk of death was 42 percent [range, 3 to 85 percent]). Dose increments were limited by complications in 24 patients in the treatment group. Twelve patients had tachycardia at a rate above 130 beats per minute despite the maintenance of an optimal pulmonary-artery occlusion pressure, eight had electrocardiographic signs of ischemia, five became hypertensive, and two had tachyarrhythmias.
Outcome
All nine patients in whom the therapeutic goals were achieved with volume expansion alone survived to leave the hospital. The treatment and control groups did not differ significantly in the number of days of ventilation, the length of stay in the intensive care unit, or the time spent in the hospital. At the second interim analysis, both in-unit and in-hospital mortality were higher (P = 0.04) in the treatment group than in the control group (Table 2). In-unit mortality was 30 percent in the control group as compared with 50 percent in the treatment group (95 percent confidence interval, 1.2 to 38.8 percent). In-hospital mortality was 34 percent (the same as the predicted risk of death) in the control group as compared with 54 percent (predicted risk of death, 34 percent) in the treatment group (95 percent confidence interval, 0.9 to 39.1 percent) (Table 2 and Figure 4Figure 4
In-Hospital Survival of Patients in the Treatment and Control Groups.). The proportion of deaths due to intractable hypotension and cardiac events was similar in the two groups. The excess deaths in the treatment group occurred later and were attributable to multiple organ failure (Table 2 and Figure 4).In-hospital mortality in the subgroup of patients with septic shock was 52 percent (predicted risk of death, 60 percent) in the control group as compared with 71 percent (predicted risk of death, 51 percent) in the treatment group. In-hospital mortality in the subgroup of patients with the adult respiratory distress syndrome was 67 percent (predicted risk of death, 53 percent) in the control group as compared with 81 percent (predicted risk of death, 47 percent) in the treatment group. Neither of these subgroup differences was significant.
Discussion
In this prospective, randomized, controlled study of critically ill patients, treatment with intravenous dobutamine that was intended to increase the cardiac index and oxygen delivery and consumption to previously recommended levels did not improve the outcome. With the use of precise guidelines for treatment, oxygen delivery was successfully increased and maintained above the target level in the treatment group, but this increase was associated with a fall in oxygen extraction. As a result, there was no difference in oxygen consumption between the two groups, despite significantly higher values for the cardiac index and oxygen delivery in the treatment group. These findings are consistent with data recently reported in patients with septic shock9 and in a mixed group of critically ill patients10. In an earlier study of patients undergoing surgery, however, oxygen consumption was higher in the treatment group than in the control group, and mortality was reduced from 33 percent to 4 percent,5 suggesting that the increase in oxygen consumption in response to enhanced oxygen delivery may have been associated with the reversal of tissue hypoxia, the prevention of organ failure, and a consequent reduction in mortality. In a similar investigation of patients with trauma,6 oxygen consumption was increased in the treatment group and there was a trend toward a reduction in mortality, although it was not significant. In a study of high-risk patients undergoing surgery, treatment aimed at achieving a level of oxygen delivery higher than 600 ml per minute per square meter, instituted preoperatively (in most of the patients) or in the early postoperative period, reduced the 28-day mortality rate by 75 percent, although the elevation in oxygen delivery was modest and there was no increase in oxygen consumption19. The results of this study may also have been influenced by the use of dopexamine instead of dobutamine to increase oxygen delivery. Edwards et al. reported that the use of dobutamine and norepinephrine to achieve target levels for the cardiac index and oxygen delivery was associated with an increase in oxygen consumption and may have improved the outcome in patients with septic shock,7 although this finding was based on comparisons with historical controls.
The contrast between our results and those reported in previous studies5,19 may be due to differences in the patient populations, as well as in the timing of therapy and the doses of inotropic agents used. Although our patients were a heterogeneous group, the majority had undergone surgery and were typical of patients admitted to general intensive care units; most had the sepsis syndrome, septic shock, the adult respiratory distress syndrome, or a combination of these conditions. In the studies reported by Shoemaker et al.5 and Boyd et al.,19 all the patients had undergone surgery, and treatment was usually instituted preoperatively, whereas in our study pulmonary-artery flotation catheters were inserted after patients were admitted to the intensive care unit, almost always postoperatively, and often after complications had occurred on the ward. Mortality has previously been shown to be much higher in such circumstances,5 probably because it is difficult or impossible to reverse the cycle of events leading to organ damage. The median APACHE II score in the study by Boyd et al. was 8,19 which is much lower than the median score of 18 in our study.
Unlike the protocol in other studies,5,6,10 an important feature of our investigation was that patients in whom the hemodynamic goals were achieved with fluid administration alone were not randomly assigned to the treatment or control group. Shoemaker and coworkers were successful in achieving the hemodynamic goals with fluid administration alone in two thirds of their patients,20 suggesting that the improved outcome in their study may have been largely related to more aggressive volume replacement. Although neither morbidity nor mortality was improved by the regimen used in our treatment group, it is important to note that when all the patients in our study are considered, including the 9 who were not randomized, all but 2 of the 33 patients in whom target values for the cardiac index and oxygen delivery and consumption were achieved survived to leave the hospital. This supports the idea that the ability to achieve the desired levels of oxygen delivery and consumption indicates a larger physiologic reserve, less severe illness, and consequently, a better prognosis.
It is unclear why the outcome was worse in the treatment group, since randomization resulted in well-matched groups and there was no difference in mean arterial pressure between the groups. It is conceivable that the larger doses of dobutamine used in the treatment group limited the rise in oxygen consumption by exacerbating the maldistribution of blood flow within the microcirculation, resulting in impaired perfusion of vital organs, such as the gastrointestinal tract, and thereby contributing to the higher incidence of multiple-organ failure in the treatment group. The larger doses of dobutamine administered to patients in the treatment group may also explain the greater need for norepinephrine in this group, and the possibility that norepinephrine further exacerbated tissue ischemia cannot be excluded.
We conclude that when volume replacement was adequate and perfusion pressure well maintained, the overall outcome in high-risk patients was not improved by using dobutamine at the time of admission to the intensive care unit in an attempt to achieve target values for oxygen delivery and consumption. Not only was it often impossible to increase oxygen consumption, but our results also suggest that in some cases aggressive efforts to boost oxygen consumption may have been detrimental. Further studies will be required to establish whether these results apply to homogeneous subgroups of patients, such as those with trauma or septic shock, and whether less aggressive treatment that is more precisely tailored to an individual patient's requirements may be more effective. It remains to be seen whether there are advantages to targeting oxygen delivery rather than oxygen consumption and whether other inotropic agents may have a more favorable effect on oxygen consumption. The effect of preoperative rather than postoperative institution of therapy in patients undergoing emergency surgery and in those undergoing elective surgery also merits further investigation.
Supported by a grant from the North East Thames Regional Health Authority, administered through the Joint Research Board and Medical College, St. Bartholomew's Hospital. Dr. Yau is the recipient of an Aylwen bursary from the Medical College of St. Bartholomew's Hospital.
We are indebted to the nursing staff of the intensive care units at St. Bartholomew's Hospitals at Smithfield and Homerton for their enthusiasm and cooperation while this study was in progress, to the consultant staff at both institutions for permission to study their patients, to Miss Janice Thomas for statistical advice, and to Dr. Cyril Vesey for measuring lactate concentrations.
Source Information
From the Departments of Anesthesia and Intensive Care, St. Bartholomew's Hospitals at Smithfield and Homerton (M.A.H., A.C.T., E.H.S.Y., C.J.H., D.W.), and the Departments of Anesthesia and Intensive Care, Charing Cross Hospital (M.P.) -- all in London.
Address reprint requests to Dr. Watson at the Department of Anesthesia, St. Bartholomew's Hospital at Smithfield, West Smithfield, London EC1A 7BE, United Kingdom.
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