Cardiac Surgery for Rheumatic Valvular Heart DiseasePhase 2NCT01704482
N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement
A Phase 2 study testing N-acetylcysteine in people with Cardiac Surgery for Rheumatic Valvular Heart Disease and Renal Dysfunction, run by Assiut University at 1 site in Egypt.
Trial summary
We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal dysfunction in patients with rheumatic valvular heart disease undergoing single valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery for Rheumatic Valvular Heart Disease, Renal Dysfunction
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2011to Sep 2012
- 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
- patients with rheumatic heart disease undergoing single valve replacement
Who cannot join
- End stage renal disease (plasma creatinine concentration ≥ 300 µmol/L)
- Emergency cardiac surgery
- Planned off-pump cardiac surgery
- Chronic inflammatory disease on immunosuppression
- Chronic moderate to high dose corticosteroid therapy (≥ 10 mg/day prednisone or equivalent)
- Age ≤ 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement.
We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal dysfunction in patients with rheumatic valvular heart disease undergoing single valve replacement.
- Being tested
- N-acetylcysteine, placebo
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
NAC bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | N-acetylcysteine bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs Receives: Drug: N-acetylcysteine |
| Glucose 5% | Placebo comparator | equivalent volume over the same period. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in serum creatinine from baseline to peak level
Measured: within 5 days after surgery
Secondary outcomes (1)
the relative change in serum creatinine.
Measured: the first five postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery for Rheumatic Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Samy Abbas, Assiut University
- Investigators
- Laila H Mohamed, Prof, Study chair, Assiut university hosiptalNawal A Gad El-rab, Prof, Study director, Assiut university hosiptalFatma A Abd El-Aal, Ass Prof, Study director, Assiut university hosiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704482
- Sponsor's protocol ID
- tafanono01003060187
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement.
- ClinicalTrials.gov ID
- NCT01704482
- Acronym / sponsor ID
- tafanono01003060187
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Oct 2012 (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.
We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal dysfunction in patients with rheumatic valvular heart disease undergoing single valve replacement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-acetylcysteineN-acetylcysteine bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs |
| Glucose 5% | Placebo comparator | Drug: placeboequivalent volume over the same period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with rheumatic heart disease undergoing single valve replacement
Key exclusion criteria (6 listed)
- End stage renal disease (plasma creatinine concentration ≥ 300 µmol/L)
- Emergency cardiac surgery
- Planned off-pump cardiac surgery
- Chronic inflammatory disease on immunosuppression
- Chronic moderate to high dose corticosteroid therapy (≥ 10 mg/day prednisone or equivalent)
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-acetylcysteineNAC bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs | Drug | N-acetylcysteine |
| placebo | Drug | Glucose 5% |
Primary outcome
Absolute change in serum creatinine from baseline to peak level
Time frame: within 5 days after surgery
1 secondary outcome
the relative change in serum creatinine.
Time frame: the first five postoperative days
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 11 Oct 2012.
Related trials for Cardiac Surgery for Rheumatic Valvular Heart Disease
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Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
Rheumatic Heart Disease With Valvulitis
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.
Laila H Mohamed, Prof study chair
Assiut university hosiptal
Nawal A Gad El-rab, Prof study director
Assiut university hosiptal
Fatma A Abd El-Aal, Ass Prof study director
Assiut university hosiptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with Cardiac Surgery for Rheumatic Valvular Heart Disease and Renal Dysfunction, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 6 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 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. Some participants in this study may receive a placebo. 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?
Absolute change in serum creatinine from baseline to peak level (time frame: within 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2012.