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The Goal dIrected perFusion Trial in Cardiac Surgery

NCT02250131 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-11-24

No results posted yet for this study

Summary

Previous studies (1-5) have demonstrated that oxygen delivery (DO2) and carbon dioxide production (VCO2) during cardiopulmonary bypass (CPB) are associated with renal outcome in cardiac surgery. The critical value for DO2 is around 262 - 272 mL/min/m2, and the correspondent critical value of DO2/VCO2 ratio is around 5.0.

Patients with nadir DO2 and DO2/VCO2 ratio below these critical levels have an increased incidence of acute kidney injury (AKI) after cardiac operations.

These observations offer an interpretation for the well-known deleterious effects of excessive hemodilution during CPB, supported by many studies where an association between nadir hematocrit (HCT) on CPB and bad outcomes (especially renal) was found (6-8). It is reasonable to hypothesize that a low oxygen delivery may determine an ischemic damage to the kidney, that due to its peculiar circulation is particularly susceptible to a decrease in the oxygen supply.

However, there is no evidence that a strategy directed towards the specific goal of avoiding critical values of DO2 during CPB may actually decrease the postoperative AKI rate.

The present study is designed to verify the hypothesis that a strategy based on a goal-directed perfusion, aimed to avoid a nadir DO2 below the critical threshold, is effective in limiting the postoperative AKI rate.

Conditions

Interventions

PROCEDURE

Perfusion targeted at oxygen delivery

Flow on cardiopulmonary bypass based on a target oxygen delivery \> 280 mL/min/m2

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Principal Investigators

  • Marco Ranucci, MD · IRCCS Policlinico S. Donato

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250131 on ClinicalTrials.gov