Introduction
Materials and methods
Study identification
Study selection
Methodological quality assessment
Score | |||
---|---|---|---|
Criterion | 0 | 1 | 2 |
Method | |||
Randomization | Not randomized | Randomized | |
Blinding | Not blinded | Double-blind | |
Analysis | Other | Intention-to-treat | |
End-point mortality | No mortality as end point | Secondary end-point | Primary end-point |
Population | |||
Patient selection | Selected patients or unclear | Consecutive eligible patients | |
Comparability at baseline | No or unclear | Yes | |
Extent of follow-up | Incomplete | Complete | |
Intervention | |||
Treatment protocol | Unclear | Reproducible | |
Co-interventions | Not described | Described, but not equal or unclear | Well described and equal |
Crossover | Not described | >10% | <10% |
Statistical analysis
Results
Study inclusion and allocation
Study results
Study | Population | Intervention | Blinding | Allocation concealment | Co-interventions | Crossover | Mortality end-point | Score | Goals of treatment |
---|---|---|---|---|---|---|---|---|---|
Schultz et al. 1985 [32] | Hip fractured patients | Fluids and inotropes peri-operatively | No | Adequate | Not described | Unclear | Yes | 8 | LVSW/PCWP optimized according to normogram |
Shoemaker et al. 1988 [3] | High-risk surgical patients | Fluids and inotropes begun pre-operatively | No | Inadequate | Not described | Unclear | Yes | 5 | CI > 4.5, DO2 > 600, VO2 > 170 |
Berlauk et al. 1991 [35] | Peripheral vascular surgical patients | Fluids, afterload reduction and inotropes | No | Adequate | Not described | Unclear | Yes | 9 | CI > 2.8, 8 < PCWP < 15, SVR 1,100 |
Fleming et al. 1992 [24] | Trauma patients | Fluids, blood and dobutamine | No | Inadequate | Not described | >10% | Yes | 7 | CI > 4.5, DO2 > 670, VO2 > 166 |
Boyd et al. 1993 [25] | High-risk surgical patients | Fluids and dopexamine | No | Adequate | Described, but not equal | Unclear | Yes | 10 | DO2 > 600 |
Bishop et al. 1995 [26] | Cardiac surgical patients | Fluids and dobutamine | No | Adequate | Not described | >10% | Yes | 10 | CI > 4.5, DO2 > 670, VO2 > 166, PCWP 18 |
Mythen and Webb 1995 [33] | Cardiac surgical patients | Fluids | No | Adequate | Not described | Unclear | Yes | 8 | SV optimized |
Bender et al. 1997 [36] | Elective vascular surgical patients | Fluids, blood, vasodilators, nitroprusside and dopamine | No | Adequate | Not described | Unclear | Yes | 8 | 8 PCWP 14, CI 2.8, SVR 1,100 |
Ziegler et al. 1997 [29] | Elective vascular surgical patients | Fluids, blood, inotropes and vasodilators | No | Adequate | Not described | Unclear | Yes | 9 | SvO2 > 65, PCWP > 12, Hb > 10 |
Sinclair et al. 1997 [34] | Hip fractured patients | Fluids | No | Adequate | Not described | >10% | Yes | 8 | SV optimized to 0.35 < FTc < 0.40 |
Valentine et al. 1998 [37] | Elective aortic surgical patients | Fluids, nitroprusside, nitroglycerine and dopamine | No | Adequate | Not described | Unclear | Yes | 10 | CI > 2.8, 8 PCWP 15, SVR 1,100 |
Ueno et al. 1998 [12] | Elective hepatic surgical patients | Fluids and dobutamine | No | Adequate | Not described | Unclear | No | 7 | CI > 4.5, DO2 > 600, VO2 > 170 |
Boldt et al. 1998 [38] | Pancreatic surgical patients | Dopexamine | Yes | Adequate | Not described | Unclear | No | 8 | MAP 70, CI > 2.5, 12 < PCWP < 14 |
Wilson et al. 1999 [13] | High-risk surgical patients | Dopexamine or noradrenaline | Yes | Adequate | Described, but not equal | Unclear | Yes | 12 | DO2 > 600 |
Lobo et al 2000 [23] | High-risk surgical patients | Fluids and dobutamine | No | Adequate | Described, but not equal | >10% | Yes | 11 | DO2 > 600 |
Velhamos et al. 2000 [14] | Trauma surgical patients | Fluids, blood, inotropes and vasopressors | No | Adequate | Not described | >10% | Yes | 11 | CI > 4.5, DO2 > 600, VO2 > 170, SpO2/FiO2 > 200 |
Polonen et al. 2000 [31] | Cardiac surgical patients | Fluids, blood and inotropes | No | Adequate | Not described | >10% | Yes, but secondary | 7 | SvO2 > 70, lactate levels < 2.0 |
Takala et al. 2000 [15] | High-risk surgical patients | Fluids, blood and dopexamine | Yes | Adequate | Not described | >10% | Yes | 13 | DO2 > 600 |
Bonazzi et al. 2002 [28] | Elective vascular surgical patients | Fluids, inotropes, vasodilators | No | Adequate | Adequate | Unclear | No | 10 | CI > 3.0, 10 < PCWP < 18, SVR < 1,450, DO2 > 600 |
Conway et al. 2002 [39] | Elective gastro-intestinal surgical patients | Fluids | No | Inadequate | Not described | Unclear | Yes | 8 | CO optimized |
Sandham et al. 2003 [40] | High-risk surgical patients | Fluids, blood, inotropes, vasodilators, vasopressors | No | Adequate | Not described | <10% | Yes | 11 | 550 < DO2 < 600, 3.5 < CI < 4.5 |
Study | Population | Intervention | Blinding | Allocation concealment | Co-interventions | Crossover | Mortality end-point | Score | Goals of treatment |
---|---|---|---|---|---|---|---|---|---|
Tuchschmidt et al. 1992 [16] | Septic shock patients | Fluids, inotropes | No | Inadequate | Not described | >10% | Yes | 9 | CI > 6, SAP > 90 |
Yu et al. 1993 [17] | Sepsis, septic shock, ARDS patients | Fluids, blood, inotropes | No | Inadequate | Not described | >10% | Yes | 8 | DO2 > 600 |
Hayes et al. 1994 [20] | Post-operative patients, sepsis, respiratory failure | Fluids, dobutamine | No | Adequate | Not described | Unclear | Yes | 10 | CI > 4.5, DO2 > 600, VO2 > 170 |
Gattinoni et al. 1995 [22] | High-risk postoperative patients, sepsis, respiratory failure | Fluids and inotropes | No | Adequate | Described, but not adequate | <10% | Yes | 12 | CI > 4.5 or SvO2 > 70% |
Yu et al. 1995 [18] | Sepsis, septic shock, ARDS or hypovolemic shock patients | Fluids, inotropes and vasopressors | No | Inadequate | Not described | >10% | Yes | 8 | DO2 > 600 |
Yu et al. 1998 [19] | SIRS, sepsis, severe sepsis, septic shock, ARDS patients 50–75 years of age | Fluids, afterload reduction, inotropes, amrinone, vasopressors | No | Adequate | Not described | Unclear | Yes | 8 | DO2 > 600 |
Yu et al. 1998 [19] | SIRS, sepsis, severe sepsis, septic shock, ARDS patients >75 years of age | Fluids, afterload reduction, inotropes, amrinone, vasopressors | No | Adequate | Not described | Unclear | Yes | 8 | DO2 > 600 |
Durham et al. 1996 [27] | Critically ill patients | Fluids, inotropes and nitroprusside | No | Adequate | Not described | Unclear | Yes | 9 | DO2 > 600, VO2 > 150 |
Alia et al. 1999 [21] | Septic shock patients or severe sepsis patients | Dobutamine | No | Adequate | Not described | >10% | Yes | 10 | DO2 > 600 |
Rivers et al. 2001 [30] | Severe sepsis and septic shock | Fluids, blood, inotropes and vasopressors | No | Adequate | Not described | >10% | Yes | 11 | SvO2 > 70% |
Subset analysis
Peri-operative and trauma studies versus studies using septic/organ failure patients
Supranormal oxygen delivery as a goal of treatment
Trial category | Odds ratio (95% CI) | Relative risk (95% CI) | p for heterogeneity |
---|---|---|---|
Peri-operative trials | |||
Cardiac index, DO2 or VO2 | 0.41 (0.29–0.59) | 0.49 (0.36–0.65) | 0.1 |
Other goals | 0.83 (0.62–1.11) | 0.84 (0.64–1.10) | 0.3 |
Sepsis/organ failure trials | |||
Cardiac index, DO2 or VO2 | 1.00 (0.77–1.30) | 1.00 (0.90–1.11) | 0.09 |
Other goals | 0.77 (0.38–1.57) | 0.85 (0.55–1.31) | 0.01 |
All trials | |||
Cardiac index, DO2 or VO2 | 0.60 (0.42–0.88) | 0.75 (0.60–0.95) | 0.0003 |
Other goals | 0.83 (0.68–1.03) | 0.90 (0.80–1.01) | 0.09 |
Score | |||
≥10 | 0.84 (0.66–1.07) | 0.74 (0.51–1.08) | 0.0005 |
<10 | 0.45 (0.32–0.64) | 0.60 (0.48–0.75) | 0.6 |
End-point | |||
Mortality as primary end-point | 0.63 (0.46–0.85) | 0.76 (0.63–0.93) | <0.0001 |
Secondary or no mortality end-point | 0.34 (0.13–0.93) | 0.36 (0.14–0.94) | 1.0 |
Blinding | |||
Yes | 0.61 (0.36–1.04) | 0.64 (0.40–1.03) | 0.1 |
No | 0.62 (0.46–0.84) | 0.77 (0.63–0.93) | 0.0008 |
Crossover | |||
Yes | 0.43 (0.25–0.77) | 0.52 (0.32–0.83) | 0.003 |
No | 0.85 (0.71–1.01) | 0.86 (0.73–1.02) | 0.05 |
Quality assessment score
Mortality end-point
Blinding
Crossover
Discussion
Conclusion
Key messages
-
Peri-operative interventions aimed at the hemodynamic optimization of high-risk surgical patients reduce mortality.
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The use of hemodynamic optimization as a therapy to improve outcome during sepsis with established organ failure does not reduce mortality.
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Although there is no clear relationship between overall trial quality and outcome of all trials, individual quality assessment items influenced study outcome.