Postoperative Complications Clinical Trial
— GDTPPVOfficial title:
A Pragmatic Multi-center Trial of Goal-directed Fluid Management Based on Pulse Pressure Variation Monitoring During High-risk Surgery
Verified date | April 2017 |
Source | Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Intraoperative fluid therapy guided by mechanical ventilation-induced
pulse-pressure variation (PPV) may improve outcomes after major surgery. It was tested this
hypothesis in a multi-center study.
Methods: The patients were included in two periods: a first control period (control group;
n=147) in which intraoperative fluids were given according to clinical judgment. After a
training period, intraoperative fluid management was titrated to maintain PPV< 10% in 109
surgical patients (PPV group). It was performed 1:1 propensity score matching to ensure the
groups were comparable with regard to age, weight, duration of surgery, and type of
operation. The primary endpoint was postoperative hospital length of stay.
Status | Completed |
Enrollment | 256 |
Est. completion date | June 30, 2010 |
Est. primary completion date | June 1, 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - high-risk patients undergoing open major surgery under general anesthesia and who required ICU admission postoperatively Exclusion Criteria: - Patients with severe aortic regurgitation, cardiac arrhythmias, congestive heart failure, patients undergoing renal replacement therapy, those undergoing palliative surgery were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo | Federal University of São Paulo, Hospital Padre Albino of Catanduva Medical School, University of Sao Paulo |
Auler JO Jr, Galas F, Hajjar L, Santos L, Carvalho T, Michard F. Online monitoring of pulse pressure variation to guide fluid therapy after cardiac surgery. Anesth Analg. 2008 Apr;106(4):1201-6, table of contents. doi: 10.1213/01.ane.0000287664.03547.c6. — View Citation
Doherty M, Buggy DJ. Intraoperative fluids: how much is too much? Br J Anaesth. 2012 Jul;109(1):69-79. doi: 10.1093/bja/aes171. Epub 2012 Jun 1. Review. — View Citation
Jhanji S, Thomas B, Ely A, Watson D, Hinds CJ, Pearse RM. Mortality and utilisation of critical care resources amongst high-risk surgical patients in a large NHS trust. Anaesthesia. 2008 Jul;63(7):695-700. doi: 10.1111/j.1365-2044.2008.05560.x. Epub 2008 — View Citation
Lobo SM, Rezende E, Knibel MF, Silva NB, Páramo JA, Nácul FE, Mendes CL, Assunção M, Costa RC, Grion CC, Pinto SF, Mello PM, Maia MO, Duarte PA, Gutierrez F, Silva JM Jr, Lopes MR, Cordeiro JA, Mellot C. Early determinants of death due to multiple organ f — View Citation
Lobo SM, Salgado PF, Castillo VG, Borim AA, Polachini CA, Palchetti JC, Brienzi SL, de Oliveira GG. Effects of maximizing oxygen delivery on morbidity and mortality in high-risk surgical patients. Crit Care Med. 2000 Oct;28(10):3396-404. — View Citation
Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. — View Citation
Pearse RM, Harrison DA, James P, Watson D, Hinds C, Rhodes A, Grounds RM, Bennett ED. Identification and characterisation of the high-risk surgical population in the United Kingdom. Crit Care. 2006;10(3):R81. Epub 2006 Jun 2. — View Citation
Silva JM Jr, de Oliveira AM, Nogueira FA, Vianna PM, Pereira Filho MC, Dias LF, Maia VP, Neucamp Cde S, Amendola CP, Carmona MJ, Malbouisson LM. The effect of excess fluid balance on the mortality rate of surgical patients: a multicenter prospective study — View Citation
Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. — View Citation
Suzuki S, Woinarski NC, Lipcsey M, Candal CL, Schneider AG, Glassford NJ, Eastwood GM, Bellomo R. Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial. J Crit Care. 2014 Dec;29(6):992-6. doi: 10.1016/j.jcrc.2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative length of stay | Length of hospital stay postoperatively | up to 90 days | |
Secondary | Fluids administered postoperatively | total volume of infused fluids at 24 h after ICU admission | 1 day postoperatively | |
Secondary | Number of patients transfused postoperatively | RBCP transfusion At 24 h after ICU admission | 1 day postoperatively | |
Secondary | organ dysfunction postoperatively | incidence of organ dysfunction postoperatively (vasopressor required, mechanical ventilator required, Thrombocytopenia, Worsening liver function) | up to 30 days | |
Secondary | Number of patients with postoperative complications | incidence of postoperative complications (infection, reoperation, bleeding events) | up to 30 days | |
Secondary | hospital mortality rate | hospital mortality rate of patients | up to 30 days |
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