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Randomized Trial of Pulsatile vs Non Pulsatile Perfusion on Short Term Changes in Kidney Function Using an Intra-Aortic Ballooon Pump During Cardioplegic Arrest in Patients Undergoing Myocardial Reperfusion

NCT00454428 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2007-03-30

No results posted yet for this study

Summary

Linear flow during cardiopulmonary bypass (CPB) frequently induces renal damage.

We will evaluate whether automatic intra-aortic balloon pump (IABP) induce pulsatile perfusion preserves renal function in patients undergoing myocardial revascularization at different risk for renal damage.

100 patients undergoing preoperative IABP will be stratified for renal function.

Intervention. The patients will be randomized to non-pulsatile CPB during cardioplegic arrest or automatic IABP induced pulsatile CPB.

Renal function, daily diuretics, complication rate, lactatemia and other biochemical indices will be compared in patients.

We will prospectively enrolle 100 patients undergoing isolated primary high-risk coronary artery bypass grafting for severe left main stem disease (70% narrowing) or left-main equivalent three-vessels coronary disease. On admission to our institution, the patients will be stratified for renal function according to KDOQI and randomly assigned to Group A or Group B. We will exclude from the study patients older than 75 years, and/or with kidney disease ≥ Stage 4 (GFR 15 - 29 ml/min/1.73 m2), and/or with other splanchnic organ comorbidities (liver or mesenteric impairment, abdominal aortic aneurysm, abdominal arteries vasculopathy), and/or severe autoimmune disease.

The patients randomized to Group A (n=50) will receive a preoperative IABP treatment before induction of anesthesia, with IABP turned off during cardioplegic arrest, and restarted with a 1:1 IABP mode immediately after cross-clamp removal (as is the traditionally adopted perioperative IABP support); the other 50 (Group B) will receive standard preoperative treatment with IABP, which will switche into an automatic 80 bpm mode during cross-clamp time, and switche again into a 1:1 IABP after cross-clamp removal, in order to achieve a pulsatile perfusion during the entire intra-operative time-course.

The patients will be stratified in 2 subgroups according to the preoperative renal function: a subgroup will include 64 patients (32 allocated in Group A and 32 in Group B) with stage 1 or 2 \[Stage 1: GFR ≥90 ml/min/1.73 m2 - Stage 2: GFR 60 - 89 ml/min/1.73 m2\] and therefore considered at lower-risk for post-CPB renal damage; the remaining 36 (18 for each group) with KDOQI Stage 3 of kidney disease (GFR 30 - 59 ml/min/1.73 m2) will be considered at higher-risk for perioperative renal complications \[19\].

Conditions

  • Aortocoronary Bypass

Interventions

PROCEDURE

pulsatile intra-aortic balloon pump

Sponsors & Collaborators

  • University of Catanzaro

    lead OTHER

Principal Investigators

  • Francesco Onorati, MD · cardiac surgery

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Italy

Study Locations

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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 NCT00454428 on ClinicalTrials.gov