NCT02250131

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

September 22, 2014

Last Update Submit

November 20, 2023

Conditions

Acute Kidney Injury

Keywords

cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative AKI

    Acute kidney injury defined according to the AKIN criteria (stage 1, stage 2, any AKI, serum creatinine increase)

    48 postoperative hours

Secondary Outcomes (4)

  • ICU stay

    15 postoperative days

  • Transfusion of red blood cells

    15 postoperative days

  • Major morbidity

    15 postoperative days

  • Mortality

    30 days after surgery

Study Arms (2)

Control

NO INTERVENTION

Routine cardiopulmonary bypass technique. Flow adjusted on BSA and temperature

Goal Directed Perfusion

ACTIVE COMPARATOR

Perfusion targeted at oxygen delivery

Procedure: Perfusion targeted at oxygen delivery

Interventions

Perfusion targeted at oxygen deliveryPROCEDURE

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

Also known as: Cardiopulmonary bypass machine
Goal Directed Perfusion

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing cardiac operations with CPB. Expected CPB duration \> 90 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

Related Publications (4)

  • Ranucci M. Perioperative renal failure: hypoperfusion during cardiopulmonary bypass? Semin Cardiothorac Vasc Anesth. 2007 Dec;11(4):265-8. doi: 10.1177/1089253207311141.

    PMID: 18270190RESULT

  • Ranucci M, Isgro G, Romitti F, Mele S, Biagioli B, Giomarelli P. Anaerobic metabolism during cardiopulmonary bypass: predictive value of carbon dioxide derived parameters. Ann Thorac Surg. 2006 Jun;81(6):2189-95. doi: 10.1016/j.athoracsur.2006.01.025.

    PMID: 16731152RESULT

  • Ranucci M, Romitti F, Isgro G, Cotza M, Brozzi S, Boncilli A, Ditta A. Oxygen delivery during cardiopulmonary bypass and acute renal failure after coronary operations. Ann Thorac Surg. 2005 Dec;80(6):2213-20. doi: 10.1016/j.athoracsur.2005.05.069.

    PMID: 16305874RESULT

  • de Somer F, Mulholland JW, Bryan MR, Aloisio T, Van Nooten GJ, Ranucci M. O2 delivery and CO2 production during cardiopulmonary bypass as determinants of acute kidney injury: time for a goal-directed perfusion management? Crit Care. 2011 Aug 10;15(4):R192. doi: 10.1186/cc10349.

    PMID: 21831302RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Marco Ranucci, MD

    IRCCS Policlinico S. Donato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiothoracic Anesthesia and ICU Dept

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 26, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)