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

This study has been completed.
Sponsor:
Information provided by:
University of Cantanzaro
ClinicalTrials.gov Identifier:
NCT00454428
First received: March 29, 2007
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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].


Condition Intervention Phase
Aortocoronary Bypass
Procedure: pulsatile intra-aortic balloon pump
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by University of Cantanzaro:

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients older than 75 years
  • With kidney disease ≥ Stage 4 (GFR 15 – 29 ml/min/1.73 m2)
  • With other splanchnic organ comorbidities (liver or mesenteric impairment, abdominal aortic aneurysm, abdominal arteries vasculopathy)
  • Severe autoimmune disease.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00454428

Locations
Italy
Cardiac Surgery and Nephrology
Catanzaro, Italy, 88100
Sponsors and Collaborators
University of Cantanzaro
Investigators
Principal Investigator: Francesco Onorati, MD cardiac surgery
  More Information

No publications provided by University of Cantanzaro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00454428     History of Changes
Other Study ID Numbers: 27579
Study First Received: March 29, 2007
Last Updated: March 29, 2007
Health Authority: Italy: Ethics Committee

Keywords provided by University of Cantanzaro:
Bypass Surgery
Coronary Artery

ClinicalTrials.gov processed this record on August 18, 2014