Acute Renal FailureNCT01907061
Acute Renal Failure Post Liver Transplantation
A study testing N-acetylcysteine in people with Acute Renal Failure, run by Baylor Research Institute at 1 site in United States.
Trial summary
Trial to test the effect of administering N-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Acute Renal Failure
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2014
- Phase
- Interventional
- 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 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First liver transplant
- Normal renal function before transplantation [serum creatinine ≤ 1.5 mg / dl]
- No requirements for dialysis before transplantation
- Age greater than 18 years
Who cannot join
- Re-transplant
- Renal dysfunction i.e. serum creatinine > 1.5 mg/dl
- Need for dialysis before transplantation
- Presence of Hepatorenal or Hepatopulmonary syndrome*
- Combined liver and kidney transplant
- Peptic ulcer disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas
Dallas, Texas, 75246
About this study
Official title: Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress
Trial to test the effect of administering N-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant
Read the detailed description
- To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
- To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
- To determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation
- Conditions
- Acute Renal Failure
- Being tested
- N-acetylcysteine, Placebo
- Keywords
- acute renal failure, post liver transplant
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Also called NAC
drug will be administered via IV,NG
PlaceboDrug
Also called Placebo in place of NAC
placebo or NAC will be given
| Study group | Role | What they receive |
|---|---|---|
| 600 mg N-acetylcysteine or placebo IV | Active comparator | 600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion, Receives: Drug: N-acetylcysteine; Drug: Placebo |
| 600 mg N-acetylcysteine or placebo NG | Active comparator | 600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion, Receives: Drug: N-acetylcysteine; Drug: Placebo |
| N-acetylcysteine or placebo q 12 hour | Active comparator | 600 mg NAC or placebo administered via NG tube every 12 hrs + 30 min for 3 additional doses (at 24, 36 and 48 hrs post O.R. infusion). The total administration will be 3000 mg over a 48 hr period. Receives: Drug: N-acetylcysteine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
Cytokines in patients receiving N-acetylcysteine versus those receiving placebo during liver transplantation will be compared.
Measured: 6 months
Secondary outcomes (2)
To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
F2-isoprostanes levels in the two groups will be compared to evaluate the role in acute renal failure and acute rejection in patients recieving a liver transplant
Measured: 6 months
iTo determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation
N-acetylcysteine or placebo will be given to patients recieving a liver tranplant cytokines and oxidative stress markers will be compared between the two groups to determine if N-acetylcysteine will impact acute renal failure post liver transplantation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2007
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yousri M. Barri, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907061
- Sponsor's protocol ID
- 007-157
- Status last verified
- Feb 2020
- First submitted
- 16 Nov 2012
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress
- ClinicalTrials.gov ID
- NCT01907061
- Acronym / sponsor ID
- 007-157
- Conditions
- Acute Renal Failure
- Keywords
- acute renal failure, post liver transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Jul 2013 (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.
Trial to test the effect of administering N-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant
Detailed description
- To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
- To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
- To determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 600 mg N-acetylcysteine or placebo IV | Active comparator | Drug: N-acetylcysteine, Drug: Placebo600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion, |
| 600 mg N-acetylcysteine or placebo NG | Active comparator | Drug: N-acetylcysteine, Drug: Placebo600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion, |
| N-acetylcysteine or placebo q 12 hour | Active comparator | Drug: N-acetylcysteine, Drug: Placebo600 mg NAC or placebo administered via NG tube every 12 hrs + 30 min for 3 additional doses (at 24, 36 and 48 hrs post O.R. infusion). The total administration will be 3000 mg over a 48 hr period. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First liver transplant
- Normal renal function before transplantation [serum creatinine ≤ 1.5 mg / dl]
- No requirements for dialysis before transplantation
- Age greater than 18 years
Key exclusion criteria (7 listed)
- Re-transplant
- Renal dysfunction i.e. serum creatinine > 1.5 mg/dl
- Need for dialysis before transplantation
- Presence of Hepatorenal or Hepatopulmonary syndrome*
- Combined liver and kidney transplant
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: NACdrug will be administered via IV,NG | Drug | 600 mg N-acetylcysteine or placebo IV, 600 mg N-acetylcysteine or placebo NG, N-acetylcysteine or placebo q 12 hour |
| PlaceboAlso: Placebo in place of NACplacebo or NAC will be given | Drug | 600 mg N-acetylcysteine or placebo IV, 600 mg N-acetylcysteine or placebo NG, N-acetylcysteine or placebo q 12 hour |
Primary outcome
To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
Time frame: 6 months
Cytokines in patients receiving N-acetylcysteine versus those receiving placebo during liver transplantation will be compared.
2 secondary outcomes
To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
Time frame: 6 months
iTo determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation
Time frame: 6 months
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 21 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Acute Renal Failure
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
Recruiting
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
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.
Yousri M. Barri, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine in people with Acute Renal Failure, run by Baylor Research Institute at 1 site in United States.
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 4 inclusion and 7 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 21 Feb 2020. 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 United States. 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.
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?
To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period (time frame: 6 months). 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 21 Feb 2020.