RhabdomyolysisPhase 2NCT00391911
Study of N-Acetylcysteine (NAC) and Continuous Renal Replacement Therapy (CRRT) for the Treatment of Rhabdomyolysis
A Phase 2 study testing N-Acetylcysteine and N-Acetylcystine and Non CRRT in people with Rhabdomyolysis, run by Royal Alexandra Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhabdomyolysis
- What is being tested?
- N-Acetylcysteine and N-Acetylcystine and Non CRRT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2006to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized Factorial Trial of N-Acetylcysteine and Continuous Veno-Venous Hemo(Dia)Filtration for Rhabdomyolysis
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.
Read more
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
Read the 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 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
- The use of N-acetylcysteine (NAC) and continuous veno-venous hemo(dia)filtration (CRRT) early in the course of rhabdomyolysis as an adjunct to 'standard therapy' (rehydration, mannitol diuresis, systemic alkalinization) respectively decreases the nephrotoxicity and improves elimination of systemic myoglobin. Consequently both therapies independently prevent the deterioration of renal glomerular and tubular function and establishment of acute renal failure.
- There exists a positive interaction between the use of N-acetylcysteine and CRRT in the prevention of acute renal failure secondary to rhabdomyolysis.
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.
- Conditions
- Rhabdomyolysis
- Being tested
- N-Acetylcysteine, N-Acetylcystine and Non CRRT, Placebo and CRRT, Placebo and Non CRRT
- Keywords
- Rhabdomyolysis, CRRT, N-Acetylcysteine
- Medical subject headings
- Rhabdomyolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDrug
Also called NAC
Patients are assigned to either N-Acetylcysteine or placebo. Dose is weight based Placebo is normal saline or D5W
N-Acetylcystine and Non CRRTOther
Also called NAC only
Patients are assigned to N-Acetylcysteine and CRRT. The N-Acetylcysteine is blinded to everyone except pharmacy. The CRRT is open label as would be impossible to blind
Placebo and CRRTOther
Also called Placebo
Patients are assigned to Placebo and CRRT. The N-Acetylcysteine/Placebo is blinded to everyone except pharmacy. The CRRT is open label
Placebo and Non CRRTOther
Also called Placebo - no CRRT
Patients are assigned to Placebo and non-CRRT. The N-Acetylcysteine/placebo is blinded to everyone except pharmacy. The CRRT/non CRRT is open label as would be impossible to blind
| Study group | Role | What they receive |
|---|---|---|
| NAC and CRRT | Active comparator | N-Acetylcysteine and CRRT Patients are assigned to N-Acetylcysteine and CRRT. The N-Acetylcysteine is blinded to everyone except pharmacy. The CRRT is open label, Receives: Drug: N-Acetylcysteine |
| NAC and non CRRT | Other | Patients are assigned to N-Acetylcysteine and CRRT. The N-Acetylcysteine is blinded to everyone except pharmacy. The CRRT is open label as would be impossible to blind Receives: Other: N-Acetylcystine and Non CRRT |
| Placebo and CRRT | Other | Patients are assigned to placebo treatment and CRRT. The N-Acetylcysteine/placebo is blinded to everyone except pharmacy. The CRRT is open label. Receives: Other: Placebo and CRRT |
| Placebo and Non CRRT | Other | Patients are assigned to Placebo and non-CRRT. This is the standard of care arm. The N-Acetylcysteine/placebo is blinded to everyone except pharmacy. The CRRT/non CRRT is open label as would be impossible to blind Receives: Other: Placebo and Non CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures include serial measurements of markers of renal glomerular function and damage and markers of renal tubular function and damage
Measured: day 1-28
Secondary outcomes (2)
Secondary outcome measures include all-cause ICU mortality and hospital mortality, ICU and hospital length of stay.
Measured: ICU admission until hospital discharge
Renal specific outcomes will include the development of Renal Failure, Loss or End Stage Kidney Disease based on the RIFLE classification system.
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Alexandra Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, Gambro Renal Products, Inc.
- Responsible party
- Principal investigator, Demetrios J. Kutsogiannis, Royal Alexandra Hospital
- Investigators
- Demetrios J. Kutsogiannis, M.D., Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391911
- Sponsor's protocol ID
- RHABDO 2006
- Other IDs
- Health Canada Control # 108739
- Status last verified
- Mar 2012
- First submitted
- 24 Oct 2006
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Abul-Ezz SR, Walker PD, Shah SV. Role of glutathione in an animal model of myoglobinuric acute renal failure. Proc Natl Acad Sci U S A. 1991 Nov 1;88(21):9833-7. doi: 10.1073/pnas.88.21.9833.
PubMed 1946409Tepel M, van der Giet M, Schwarzfeld C, Laufer U, Liermann D, Zidek W. Prevention of radiographic-contrast-agent-induced reductions in renal function by acetylcysteine. N Engl J Med. 2000 Jul 20;343(3):180-4. doi: 10.1056/NEJM200007203430304.
PubMed 10900277Briguori C, Manganelli F, Scarpato P, Elia PP, Golia B, Riviezzo G, Lepore S, Librera M, Villari B, Colombo A, Ricciardelli B. Acetylcysteine and contrast agent-associated nephrotoxicity. J Am Coll Cardiol. 2002 Jul 17;40(2):298-303. doi: 10.1016/s0735-1097(02)01958-7.
PubMed 12106935Sochman J. N-acetylcysteine in acute cardiology: 10 years later: what do we know and what would we like to know?! J Am Coll Cardiol. 2002 May 1;39(9):1422-8. doi: 10.1016/s0735-1097(02)01797-7.
PubMed 11985902Birck R, Krzossok S, Markowetz F, Schnulle P, van der Woude FJ, Braun C. Acetylcysteine for prevention of contrast nephropathy: meta-analysis. Lancet. 2003 Aug 23;362(9384):598-603. doi: 10.1016/S0140-6736(03)14189-X.
PubMed 12944058Ward MM. Factors predictive of acute renal failure in rhabdomyolysis. Arch Intern Med. 1988 Jul;148(7):1553-7.
PubMed 3382301
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Factorial Trial of N-Acetylcysteine and Continuous Veno-Venous Hemo(Dia)Filtration for Rhabdomyolysis
- ClinicalTrials.gov ID
- NCT00391911
- Acronym / sponsor ID
- RHABDO 2006
- Conditions
- Rhabdomyolysis
- Keywords
- Rhabdomyolysis, CRRT, N-Acetylcysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Royal Alexandra HospitalUniversity, hospital or other
- Collaborators
- University of Alberta, Gambro Renal Products, Inc.
- Study start
- Nov 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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
- The use of N-acetylcysteine (NAC) and continuous veno-venous hemo(dia)filtration (CRRT) early in the course of rhabdomyolysis as an adjunct to 'standard therapy' (rehydration, mannitol diuresis, systemic alkalinization) respectively decreases the nephrotoxicity and improves elimination of systemic myoglobin. Consequently both therapies independently prevent the deterioration of renal glomerular and tubular function and establishment of acute renal failure.
- There exists a positive interaction between the use of N-acetylcysteine and CRRT in the prevention of acute renal failure secondary to rhabdomyolysis.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NAC and CRRT | Active comparator | Drug: N-AcetylcysteineN-Acetylcysteine and CRRT Patients are assigned to N-Acetylcysteine and CRRT. The N-Acetylcysteine is blinded to everyone except pharmacy. The CRRT is open label, |
| NAC and non CRRT | Other | Other: N-Acetylcystine and Non CRRTPatients are assigned to N-Acetylcysteine and CRRT. The N-Acetylcysteine is blinded to everyone except pharmacy. The CRRT is open label as would be impossible to blind |
| Placebo and CRRT | Other | Other: Placebo and CRRTPatients are assigned to placebo treatment and CRRT. The N-Acetylcysteine/placebo is blinded to everyone except pharmacy. The CRRT is open label. |
| Placebo and Non CRRT | Other | Other: Placebo and Non CRRTPatients are assigned to Placebo and non-CRRT. This is the standard of care arm. The N-Acetylcysteine/placebo is blinded to everyone except pharmacy. The CRRT/non CRRT is open label as would be impossible to blind |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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% )
- Clinical suspicion of high probability of developing acute renal failure
- Informed consent
Key exclusion criteria (13 listed)
- 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:
- RIFLE category Failure defined by one of:
- RIFLE category Loss - persistent ARF =complete loss of kidney function > 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-AcetylcysteineAlso: NACPatients are assigned to either N-Acetylcysteine or placebo. Dose is weight based Placebo is normal saline or D5W | Drug | NAC and CRRT |
| N-Acetylcystine and Non CRRTAlso: NAC onlyPatients are assigned to N-Acetylcysteine and CRRT. The N-Acetylcysteine is blinded to everyone except pharmacy. The CRRT is open label as would be impossible to blind | Other | NAC and non CRRT |
| Placebo and CRRTAlso: PlaceboPatients are assigned to Placebo and CRRT. The N-Acetylcysteine/Placebo is blinded to everyone except pharmacy. The CRRT is open label | Other | Placebo and CRRT |
| Placebo and Non CRRTAlso: Placebo - no CRRTPatients are assigned to Placebo and non-CRRT. The N-Acetylcysteine/placebo is blinded to everyone except pharmacy. The CRRT/non CRRT is open label as would be impossible to blind | Other | Placebo and Non CRRT |
Primary outcome
The primary outcome measures include serial measurements of markers of renal glomerular function and damage and markers of renal tubular function and damage
Time frame: day 1-28
2 secondary outcomes
Secondary outcome measures include all-cause ICU mortality and hospital mortality, ICU and hospital length of stay.
Time frame: ICU admission until hospital discharge
Renal specific outcomes will include the development of Renal Failure, Loss or End Stage Kidney Disease based on the RIFLE classification system.
Time frame: at day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
- Background: PubMed 1946409Abul-Ezz SR, Walker PD, Shah SV. Role of glutathione in an animal model of myoglobinuric acute renal failure. Proc Natl Acad Sci U S A. 1991 Nov 1;88(21):9833-7. doi: 10.1073/pnas.88.21.9833.
- Background: PubMed 10900277Tepel M, van der Giet M, Schwarzfeld C, Laufer U, Liermann D, Zidek W. Prevention of radiographic-contrast-agent-induced reductions in renal function by acetylcysteine. N Engl J Med. 2000 Jul 20;343(3):180-4. doi: 10.1056/NEJM200007203430304.
- Background: PubMed 12106935Briguori C, Manganelli F, Scarpato P, Elia PP, Golia B, Riviezzo G, Lepore S, Librera M, Villari B, Colombo A, Ricciardelli B. Acetylcysteine and contrast agent-associated nephrotoxicity. J Am Coll Cardiol. 2002 Jul 17;40(2):298-303. doi: 10.1016/s0735-1097(02)01958-7.
- Background: PubMed 11985902Sochman J. N-acetylcysteine in acute cardiology: 10 years later: what do we know and what would we like to know?! J Am Coll Cardiol. 2002 May 1;39(9):1422-8. doi: 10.1016/s0735-1097(02)01797-7.
- Background: PubMed 12944058Birck R, Krzossok S, Markowetz F, Schnulle P, van der Woude FJ, Braun C. Acetylcysteine for prevention of contrast nephropathy: meta-analysis. Lancet. 2003 Aug 23;362(9384):598-603. doi: 10.1016/S0140-6736(03)14189-X.
- Background: PubMed 3382301Ward MM. Factors predictive of acute renal failure in rhabdomyolysis. Arch Intern Med. 1988 Jul;148(7):1553-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demetrios J. Kutsogiannis, M.D. principal investigator
University of Alberta
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-Acetylcysteine and N-Acetylcystine and Non CRRT in people with Rhabdomyolysis, run by Royal Alexandra Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures include serial measurements of markers of renal glomerular function and damage and markers of renal tubular function and damage (time frame: day 1-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391911, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.