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Sponsors and Collaborators: |
Royal Alexandra Hospital University of Alberta Gambro Renal Products, Inc. |
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Information provided by: | Royal Alexandra Hospital |
ClinicalTrials.gov Identifier: | NCT00391911 |
Rhabdomyolysis has many causes including trauma, muscle crush injuries, lack of blood supply to an arm or leg, burns, seizures, drugs and hereditary disorders. Rhabdomyolysis causes the breakdown of muscle cells and the release of a molecule called myoglobin. Myoglobin is very harmful to the kidneys and can lead to kidney failure.
Continuous dialysis has been shown to remove the myoglobin molecule from the blood in patients with rhabdomyolysis. N-Acetylcysteine (NAC) has been used in patients receiving contrast dye for x-rays and has shown less worsening of kidney function compared to patients not receiving NAC.
Early and aggressive treatment of patients with rhabdomyolysis with standard therapy, continuous dialysis and a drug called N-acetylcysteine (NAC) may prevent the development of acute kidney failure. Patients who develop kidney failure from this disorder are often critically ill and have a much higher chance of not surviving than those who do not develop kidney failure.
The purpose of this study is to determine if the use of NAC and Continuous Veno-Venous hemo(dia)filtration (CRRT)early in the course of rhabdomyolysis (in addition to standard therapy)decreases the chance of developing acute renal failure
Condition | Intervention | Phase |
---|---|---|
Rhabdomyolysis |
Drug: N-Acetylcysteine Procedure: Continuous Veno-Venous hemo(dia)filtration (CRRT) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Factorial Trial of N-Acetylcysteine and Continuous Veno-Venous Hemo(Dia)Filtration for Rhabdomyolysis |
Estimated Enrollment: | 32 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2008 |
Rhabdomyolysis may be defined as a clinical or biochemical syndrome which may result from a large variety of diseases, trauma, or toxic insults to skeletal muscle. The damage to the integrity of the sarcolemma of skeletal muscle leads to the release of potentially toxic muscle cell components into the circulation, specifically myoglobin into the plasma.
The three main principals of therapy for myoglobinuric renal failure include 1) correction of hypovolemia/ renal ischemia, 2) increase the clearance of heme proteins from both the circulation and the kidneys, 3) attenuate the adverse effects of heme proteins on the proximal tubule epithelium. Consequently, therapy for rhabdomyolysis is limited to aggressive rehydration with Ringer's lactate or normal saline, forced diuresis with mannitol, and urinary alkalinization with intravenous bicarbonate.
Hypothesis
Objectives Primary objective is to compare creatinine and myoglobin clearance as well as the glomerular filtration rate over the course of 192 hours in patients with rhabdomyolysis treated with NAC, early CRRT, both CRRT and NAC or neither of the two therapies. Secondary objectives are to : 1) Compare excretion of urine B-NAG, B1-macroglobulin, and microalbumin, as indicators of renal tubular and glomerular damage over the course of 192 hours in subjects with rhabdomyolysis treated with NAC, early CRRT, both therapies, or neither therapies 2) To compare ICU and hospital mortality and length of stay as well as the proportion of subjects with recovery of renal function at 14 and 28 days following randomization in patients with rhabdomyolysis treated with NAC, early CRRT, both therapies, or neither therapies 3) To determine clinical and biochemical risk factors for renal failure development in subjects with rhabdomyolysis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meeting any one of the following (estimated ARF risk >20% )
Exclusion Criteria:
Clinical and biochemical indications for dialysis or ultrafiltration at the time of screening:
RIFLE category Failure defined by one of:
Contact: Demetrios J. Kutsogiannis, MD MHS FRCPC | 780 735 4096 | Jim.Kutsogiannis@capitalhealth.ca |
Contact: Patrica Thompson, R.N. CCRP | 780 735 4096 | patricathompson@cha.ab.ca |
Canada, Alberta | |
Royal Alexandra Hospital | Recruiting |
Edmonton, Alberta, Canada, T5H 3V9 | |
Principal Investigator: Demetrios J. Kutsogiannis, MD MHS FRCPC | |
Sub-Investigator: Curtis Johnston, M.D. FRCPC | |
Sub-Investigator: Richard J. Johnston, MD MBA FRCPC | |
Sub-Investigator: Sam Marcushamer, M.D. FRCPC | |
Sub-Investigator: Doug Matheson, M.D. FRCPC | |
Sub-Investigator: William Murtha, M.D. FRCPC | |
Sub-Investigator: Allan Shustack, M.D. FRCPC | |
Sub-Investigator: Darren Markland, M.D. FRCPC | |
Sub-Investigator: Jon Davidow, M.D. FRCPC |
Principal Investigator: | Demetrios J. Kutsogiannis, M.D. | University of Alberta |
Study ID Numbers: | RHABDO 2006, Health Canada Control # 108739 |
Study First Received: | October 24, 2006 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00391911 |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
Rhabdomyolysis CRRT N-Acetylcysteine |
Muscular Diseases Rhabdomyolysis Musculoskeletal Diseases Acetylcysteine N-monoacetylcystine |
Anti-Infective Agents Respiratory System Agents Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Expectorants |
Physiological Effects of Drugs Free Radical Scavengers Protective Agents Antiviral Agents Pharmacologic Actions Antidotes |