NCT03128190

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2010

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

April 11, 2017

Last Update Submit

April 20, 2017

Conditions

Goal-directed Fluid TherapyHemodynamics InstabilityHigh-risk SurgeryPulse-pressure VariationPostoperative Complications

Keywords

high-risk surgerypulse-pressure variationmonitoringPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • postoperative length of stay

    Length of hospital stay postoperatively

    up to 90 days

Secondary Outcomes (5)

  • Fluids administered postoperatively

    1 day postoperatively

  • Number of patients transfused postoperatively

    1 day postoperatively

  • organ dysfunction postoperatively

    up to 30 days

  • Number of patients with postoperative complications

    up to 30 days

  • hospital mortality rate

    up to 30 days

Study Arms (2)

Control group

NO INTERVENTION

In the control period, patients were given intravenous fluids at the discretion of the anesthesiologist based on institutional protocol using 250ml of crystalloids or 100ml of colloids based on central venous pressure (CVP) and mean arterial pressure (MAP) measurements. The aim was to keep the CVP ≥ 8mmHg and MAP ≥ 65mmHg. Fluid boluses were administered up to a total of 1000ml, if patients did not attain a MAP of \>65 mmHg, a vasopressor drug was administered.

PPV group

EXPERIMENTAL

intraoperative fluid management was titrated to maintain PPV\< 10%. fluids boluses of colloids were given to maintain continuously measured PPV at 10% or less

Other: Pulse pressure variation monitoring

Interventions

Pulse pressure variation monitoringOTHER

fluids boluses of colloids were given to maintain continuously measured PPV at 10% or less

Also known as: PPV
PPV group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high-risk patients undergoing open major surgery under general anesthesia and who required ICU admission postoperatively

You may not qualify if:

  • Patients with severe aortic regurgitation, cardiac arrhythmias, congestive heart failure, patients undergoing renal replacement therapy, those undergoing palliative surgery were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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. doi: 10.1186/cc4928. Epub 2006 Jun 2.

    PMID: 16749940RESULT

  • Lobo SM, Rezende E, Knibel MF, Silva NB, Paramo JA, Nacul FE, Mendes CL, Assuncao 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 failure after noncardiac surgery in high-risk patients. Anesth Analg. 2011 Apr;112(4):877-83. doi: 10.1213/ANE.0b013e3181e2bf8e. Epub 2010 Jun 8.

    PMID: 20530615RESULT

  • 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 May 16.

    PMID: 18489613RESULT

  • 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. doi: 10.1097/00003246-200010000-00003.

    PMID: 11057792RESULT

  • 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. doi: 10.1136/bmj.315.7113.909.

    PMID: 9361539RESULT

  • 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. Crit Care. 2013 Dec 10;17(6):R288. doi: 10.1186/cc13151.

    PMID: 24326085RESULT

  • 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. doi: 10.1186/cc6117.

    PMID: 17822565RESULT

  • 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.

    PMID: 18349193RESULT

  • 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.

    PMID: 22661747RESULT

  • 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.2014.07.032. Epub 2014 Aug 7.

    PMID: 25220528RESULT

  • Malbouisson LMS, Silva JM Jr, Carmona MJC, Lopes MR, Assuncao MS, Valiatti JLDS, Simoes CM, Auler JOC Jr. A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery. BMC Anesthesiol. 2017 May 30;17(1):70. doi: 10.1186/s12871-017-0356-9.

    PMID: 28558654DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical researcher, MD, PhD

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 25, 2017

Study Start

June 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 30, 2010

Last Updated

April 25, 2017

Record last verified: 2017-04