Preventing Acute Renal Failure After Cardiac Surgery in High Risk Patients Using Sodium Bicarbonate Therapy (PARACHUTE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00522756
First received: August 29, 2007
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to determine whether sodium bicarbonate is effective in reducing kidney injury that may occur during cardiac surgery.


Condition Intervention Phase
Kidney Failure, Acute
Drug: Sodium bicarbonate
Drug: Sodium chloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Preventing Acute Renal Failure After Cardiac Surgery in High Risk Patients Using Sodium Bicarbonate Therapy (PARACHUTE) - Pilot Study

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Increase in serum creatinine of 44 micromol/L or by 25% within the first 3 days after surgery. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative vasoactive medication, intra-aortic balloon pump, mechanical ventilation, reintubation, reoperation, myocardial infarction, stroke, infection, hypokalemia, dialysis, ICU and hospital length of stay and survival. [ Time Frame: 3 weeks post operative period ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2006
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Three ampoules of 7.5% sodium bicarbonate (89.3 mOsm/ampoule; total 150 ml for three ampoules) added to 750 ml of 5% dextrose in water, given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.
Drug: Sodium bicarbonate
Three ampoules of 7.5% sodium bicarbonate (89.3 mOsm/ampoule; total 150 ml for three ampoules) added to 750 ml of 5% dextrose in water, given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.
Other Name: NaHCO3
Active Comparator: Control
0.9% sodium chloride given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.
Drug: Sodium chloride
0.9% sodium chloride given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.
Other Name: saline

Detailed Description:

Acute renal failure (ARF) is an important complication after cardiac surgery that has a prevalence ranging between 5 and 30%. In addition, the impact of chronic kidney disease (CKD) has been well correlated with poorer outcomes after cardiac surgery. These factors have been demonstrated to be associated with increased morbidity, mortality, as well as consuming limited health care resources.

Despite the identification of certain higher risk determinants such as emergency surgery, valvular surgery, preoperative creatinine level, diabetes, increasing age, obesity, and peripheral vascular disease, interventions to decrease postoperative ARF in these patients have been limited. Agents that have been successful in other settings, such as N-acetylcysteine and fenoldopam, have shown no difference in clinical outcomes of ARF when tested in randomized clinical trials in high-risk cardiac surgery patients. Although prophylactic hemodialysis has been shown to be effective for patients with underlying severe kidney disease, this is clearly a resource intensive therapy that may not be practical as a general prophylaxis strategy.

The use of sodium bicarbonate has shown efficacy in reducing the incidence of ARF due to contrast-induced nephropathy in those patients with moderate, stable renal dysfunction. The postulated mechanism of renal protection has been described through the prevention of free radical generation and damage. The generation of a higher renal proximal tubule pH with bicarbonate therapy may slow down the superoxide-generating Haber-Weiss reaction, limiting the formation of free radical oxidants. In addition, sodium bicarbonate may be directly scavenging reactive oxygen species generated from nitric oxide, at a physiologic pH.

If it is presumed that initiation and extension of ischemic renal injury occurs during cardiac surgery via oxidant injury, the use of sodium bicarbonate to disrupt this process could possibly be an effective therapeutic option to prevent ARF.

The objective of this study is to evaluate the renal protective effect of near-isotonic sodium bicarbonate as compared to sodium chloride when given as prophylaxis to patients with chronic kidney disease prior to non-emergent surgery involving the use of cardiopulmonary bypass.

Our hypothesis is that bicarbonate therapy may disrupt ischemia-induced, oxidant-mediated injury and this may prevent the propagation of renal damage. These events may be demonstrated clinically by a reduced incidence of ARF following surgery, decreased requirements for renal replacement therapy after surgery, and improved survival both perioperatively and in a longer-term follow up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • age greater than or equal to 18 years
  • elective or urgent CABG +/- valve surgery, or elective or urgent isolated valve surgery
  • exposure to cardiopulmonary bypass
  • stable kidney disease: less than 25% change in serum creatinine during 3 months before surgery
  • Estimated glomerular filtration rate, by Modification of Diet in Renal Disease (MDRD) equation, less than or equal to 60 ml/min/1.73m2

Exclusion criteria:

  • emergency CABG, cardiac transplantation, or insertion of VAD
  • planned off-pump surgery
  • N-acetylcysteine given in last 72 hours prior to operation
  • radiocontrast given in last 48 hours prior to operation
  • acute renal failure (greater than 25% increase in serum creatinine from preadmission baseline)
  • glomerular filtration rate less than 15 ml/min or chronic dialysis
  • prior renal transplantation
  • enrollment in another research study, with the exception of MUHC study SDR-05-033
  • LV ejection fraction less than or equal to 20%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522756

Contacts
Contact: Carole Albert, RN (514) 934-1934 ext 34980 carole.albert@muhc.mcgill.ca
Contact: Ahsan Alam, MD (514) 934-1934 ext 31586 ahsan.alam@mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre - Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A1A1
Principal Investigator: Benoit de Varennes, MD         
Principal Investigator: Ahsan Alam, MD         
Sub-Investigator: Danny Del Duca, MD         
Sub-Investigator: Sameena Iqbal, MD         
Sub-Investigator: Peter Goldberg, MD         
Sub-Investigator: Navdeep Tangri         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Benoit de Varennes, MD McGill University Health Center
Principal Investigator: Ahsan Alam, MD McGill University Health Center
  More Information

Publications:
Responsible Party: McGill University Health Center
ClinicalTrials.gov Identifier: NCT00522756     History of Changes
Other Study ID Numbers: SDR-05-045
Study First Received: August 29, 2007
Last Updated: October 22, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Kidney Failure, Acute
Cardiac Surgical Procedures
Sodium Bicarbonate
Sodium Chloride
Prevention and control

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014