Status:
COMPLETED
Study of N-Acetylcysteine (NAC) and Continuous Renal Replacement Therapy (CRRT) for the Treatment of Rhabdomyolysis
Lead Sponsor:
Royal Alexandra Hospital
Collaborating Sponsors:
University of Alberta
Gambro Renal Products, Inc.
Conditions:
Rhabdomyolysis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 m...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Randomization within 96 hours of medical or surgical diagnosis consistent with rhabdomyolysis
- \>18 yrs old
- 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
- Clinical suspicion of high probability of developing acute renal failure
- Informed consent
Exclusion
- Allergic reaction to N-acetylcysteine.
- Previous wish not to include dialysis as part of medical therapy.
- 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.
- 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
- RIFLE category Loss - persistent ARF =complete loss of kidney function \> 4 weeks
- Pregnancy
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00391911
Start Date
November 1 2006
End Date
December 1 2010
Last Update
March 5 2012
Active Locations (2)
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1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
2
King Fahad National Guard Hospital
Riyadh, Saudi Arabia, 11426