Chronic Kidney DiseasesPhase 1NCT01251029
Effect of N-acetylcysteine on Renal Functioning of Chronic Kidney Diseases(CKD) Patients After General Anesthesia
A Phase 1 study testing N-acetylcysteine and Siran (N-acetylcysteine) in people with Chronic Kidney Diseases and General Anesthesia, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Acute kidney injury (AKI) is one of the most serious and frequent complication of general anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases, General Anesthesia
- What is being tested?
- N-acetylcysteine and Siran (N-acetylcysteine)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2014
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from chronic kidney disease that should undergo surgical interventions under general anesthesia
Who cannot join
- pregnancy
- single kidney
- heart failure (NYHA class III-IV)
- hepatic failure
- mental diseases
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh Medical Center
Tsrifin, 70300
Zoya Haitov, MD, 972-8-9779946, ZoyaC@asaf.health.gov.il
Zoya Haitov, MD
About this study
Official title: Ability of N-acetylcysteine to Prevent Deterioration in Renal Functioning in CKD Patients Undergoing Major Surgery Under General Anesthesia
Acute kidney injury (AKI) is one of the most serious and frequent complication of general anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. CKD patients often need some surgical interventions that have been done under general anesthesia; they therefore have an increased probability to develop AKI.
N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties, reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney from injury induced by contrast media, ischemia, and toxins.
Read more
Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in renal functioning in CKD patients undergoing major surgery under general anesthesia.
Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40) patients that should undergo surgical interventions under general anesthesia and will divide to 3 groups as follows: group 1- about 40 patients which should undergo major vascular surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and B). Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery. Subgroup B will receive placebo (saline).
Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after surgery in all patients. An additional blood samples for assessment of nitric oxide and cytokine levels will be taken from each patient before and after surgery.
- Conditions
- Chronic Kidney Diseases, General Anesthesia
- Being tested
- N-acetylcysteine, Siran (N-acetylcysteine)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
1200 mg orally; 600mg i.v.
Siran (N-acetylcysteine)Drug
| Study group | Role | What they receive |
|---|---|---|
| sugar pil and saline | Experimental | Not described Receives: Drug: N-acetylcysteine; Drug: Siran (N-acetylcysteine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
parameters of kidney function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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 1
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Murat Bahar, MD, Study chair, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251029
- Sponsor's protocol ID
- 197/10
- Status last verified
- Nov 2010
- First submitted
- 25 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of N-acetylcysteine to Prevent Deterioration in Renal Functioning in CKD Patients Undergoing Major Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01251029
- Acronym / sponsor ID
- 197/10
- Conditions
- Chronic Kidney Diseases, General Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 1 Dec 2010 (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.
Acute kidney injury (AKI) is one of the most serious and frequent complication of general anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. CKD patients often need some surgical interventions that have been done under general anesthesia; they therefore have an increased probability to develop AKI.
N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties, reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney from injury induced by contrast media, ischemia, and toxins.
Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in renal functioning in CKD patients undergoing major surgery under general anesthesia.
Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40) patients that should undergo surgical interventions under general anesthesia and will divide to 3 groups as follows: group 1- about 40 patients which should undergo major vascular surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and B). Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery. Subgroup B will receive placebo (saline).
Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after surgery in all patients. An additional blood samples for assessment of nitric oxide and cytokine levels will be taken from each patient before and after surgery.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sugar pil and saline | Experimental | Drug: N-acetylcysteine, Drug: Siran (N-acetylcysteine) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients suffering from chronic kidney disease that should undergo surgical interventions under general anesthesia
Key exclusion criteria (5 listed)
- pregnancy
- single kidney
- heart failure (NYHA class III-IV)
- hepatic failure
- mental diseases
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-acetylcysteine1200 mg orally; 600mg i.v. | Drug | sugar pil and saline |
| Siran (N-acetylcysteine) | Drug | sugar pil and saline |
Primary outcome
parameters of kidney function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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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.
Murat Bahar, MD study chair
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N-acetylcysteine and Siran (N-acetylcysteine) in people with Chronic Kidney Diseases and General Anesthesia, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Dec 2010. 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 Israel. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoya Haitov, MD (972-8-9779466, ZoyaC@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parameters of kidney function. 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 1 Dec 2010.