Study of N-Acetylcysteine (NAC) and Continuous Renal Replacement Therapy (CRRT) for the Treatment of Rhabdomyolysis

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Alexandra Hospital
• Collaborators: Gambro Renal Products, Inc.; University of Alberta
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

1. Randomization within 96 hours of medical or surgical diagnosis consistent with rhabdomyolysis

2. >18 yrs old

3. Meeting any one of the following (estimated ARF risk >20% )

• CK >25,000 IU/L

• Injury Severity Score >16 and CK >5000 IU/L

• Age >55 and CK >5000 IU/L

4. Clinical suspicion of high probability of developing acute renal failure

5. Informed consent

Exclusion Criteria:

1. Allergic reaction to N-acetylcysteine.

2. Previous wish not to include dialysis as part of medical therapy.

3. Clinical and biochemical indications for dialysis or ultrafiltration at the time of screening:

• Massive fluid overload unresponsive to diuretics and requiring ultrafiltration.

• Refractory acidosis with a persistent serum pH < 7.20 despite HCO3 therapy.

• Hyperkalemia with EKG changes necessitating dialysis for the removal of potassium.

• Pericardial friction rub from uremic pericarditis.

4. RIFLE category Failure defined by one of:

• Increase serum creatinine x 3, GFR decrease 75% OR

• SCreat ≥ 4mg/dl (354 umol/L) (acute rise ≥ 0.5mg/dl [44 umol/L])

• UO < 0.3ml/kg/h x 24h or anuria x 12 hours

5. RIFLE category Loss - persistent ARF =complete loss of kidney function > 4 weeks

6. Pregnancy