Kidney Injury, AcuteNCT05555511
Perioperative Use of NAC to Prevent AKI in Patients With Pre-existing Moderate Renal Insufficiency Following Cardiac Surgery
A study of Kidney Injury, Acute, run by Ain Shams University at 1 site in Egypt.
Trial summary
Acute kidney injury (AKI) or renal impairment is an established complication of cardiac surgery occurring with an incidence up to 30%, To date, no agent has conferred renal protection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury, Acute
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Aug 2022to 26 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
- Pre-existing moderate renal insufficiency serum creatinine more than 1.5 mg/dL
Who cannot join
- Patients on hemodialysis preoperatively
- History of renal transplantation
- IV contrast within 4 days prior to surgery
- Urgent/emergent surgery
- Preoperative hemodynamic instability (intra-aortic balloon pump support or vasoactive medications)
- Planned off-pump surgery;
Show all 9Show fewer
- Planned deep-hypothermic-circulatory-arrest
- known or suspected allergy to NAC
- Patient Refusal.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cardiothoracic Academy, Ain Shams University Hospitals
Cairo, 11566
University President, +2026847819, gd.research@asu.edu.eg
Adel Alansary
About this study
Official title: Perioperative Use of N-acetylcysteine to Prevent Acute Kidney Injury in Patients With Pre-existing Moderate Renal Insufficiency Following Cardiac Surgery
Acute kidney injury (AKI) or renal impairment is an established complication of cardiac surgery occurring with an incidence up to 30%, To date, no agent has conferred renal protection. Considerable interest has developed in the potential for Nacetylcysteine (NAC) to exert a renoprotective effect in patients undergoing cardiac surgery. Due to the beneficial effect of NAC on contrast nephropathy and its reported anti-inflammatory effects.
Read the detailed description
Acute kidney injury (AKI), is a well-known complication of cardiac surgery, with an incidence of up to 30% depending on the definition. AKI caused by cardiac surgery is the second most common cause of AKI in the intensive care unit and is a common and serious postoperative complication of cardiac surgery requiring cardiopulmonary bypass (CPB).
The pathogenesis of AKI after CPB is multifactorial, and is mostly due to hypo perfusion, reperfusion injury, activation of the systemic inflammatory response, and/or low cardiac output. Reperfusion will result in the formation of reactive oxygen species, resulting in injury to tissues.
The activation of the systemic inflammatory response is mostly due to the exposure of blood to the extracorporeal CPB circuit, resulting in the activation of the immune system, which is also mediated by the generation of reactive oxygen species. This results in increased recruitment of neutrophils, macrophages, and lymphocytes into the renal parenchyma, leading to AKI.
N-acetylcysteine (NAC) is well known for its antioxidant and free-radical scavenging properties, as well as its vasodilator properties. Its antioxidant properties enable it to prevent ischemic cell death, and as a free-radical scavenger, NAC mitigates the effect of increased reactive oxygen species caused by reperfusion. Hence, theoretically, NAC is able to counteract several mechanisms of kidney injury during cardiac surgery, namely, the systemic inflammatory response, free-radical injury, and ischemia.
In this study, we aimed to investigate if the perioperative use of acetylcysteine will prevent kidney injury after cardiac surgery.
- Conditions
- Kidney Injury, Acute
- Being tested
- Control Group
- Keywords
- N-acetylcysteine, Acute kidney injury, Cardiac surgery
- 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.
Control GroupOther
Patients will not receive N-Acetylcystiene and will receive standard care according to our institutional protocol
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine group | Active comparator | (23 Patients) Patients will recieve N-acetylcysteine 600 mg intravenous(IV) every 12 hours 24 hours before surgery and will be continued for 48 hours after surgery Receives: Other: Control Group |
| Standard group | No intervention | Patients will not receive N-Acetylcysteine and will receive standard care according to our institutional protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Creatinine rise
Creatinine increase >25% or ≥ 0.5 mg/dl above baseline
Measured: 7days
Secondary outcomes (5)
RRT
Need for Renal Replacement Therapy
Measured: 7 days
Length of ICU stay
Length of stay in the ICU in days
Measured: 3 days
Length of hospital stay
Length of stay in hospital in days
Measured: 7 to 10 Days
Mortality
Mortality rate
Measured: 30 days
Adverse effects
Occurrence of NAC adverse effects as (bronchospasm, urticaria, facial edema, nausea/vomiting).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start26 Aug 2022
- Primary completion26 Jan 2023 (estimated)
- Study completion26 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Kidney Injury, AcuteStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized using computer generated random series into two groups according to the used drug into: Group A: N-acetylcysteine group (23 Patients) Patients will receive N-acetylcysteine 600 mg intravenous(IV) every 12 hours 24 hours before surgery and will be continued for 48 hours after surgery. Group B : Standard (control) group (23 Patients) Patients will not receive N-Acetylcysteine and will receive standard care according to our institutional protocol.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alaaeldin Abdelmoneem Alhadidy, Ain Shams University
- Investigators
- Mohamed A. Alhadidy, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555511
- Sponsor's protocol ID
- FMASU R 122/2022
- Status last verified
- Dec 2022
- First submitted
- 22 Sep 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SH, Kim SJ, Kim HJ, Son JS, Lee R, Yoon TG. Acute Kidney Injury Following Cardiopulmonary Bypass in Children - Risk Factors and Outcomes. Circ J. 2017 Sep 25;81(10):1522-1527. doi: 10.1253/circj.CJ-17-0075. Epub 2017 May 17.
PubMed 28515370Schopka S, Diez C, Camboni D, Floerchinger B, Schmid C, Hilker M. Impact of cardiopulmonary bypass on acute kidney injury following coronary artery bypass grafting: a matched pair analysis. J Cardiothorac Surg. 2014 Jan 18;9:20. doi: 10.1186/1749-8090-9-20.
PubMed 24438155Dexter F. Duration of cardiopulmonary bypass and outcome. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):e19; author reply e19-20. doi: 10.1053/j.jvca.2011.12.012. Epub 2012 Jan 29. No abstract available.
PubMed 22285125Nadim MK, Forni LG, Bihorac A, Hobson C, Koyner JL, Shaw A, Arnaoutakis GJ, Ding X, Engelman DT, Gasparovic H, Gasparovic V, Herzog CA, Kashani K, Katz N, Liu KD, Mehta RL, Ostermann M, Pannu N, Pickkers P, Price S, Ricci Z, Rich JB, Sajja LR, Weaver FA, Zarbock A, Ronco C, Kellum JA. Cardiac and Vascular Surgery-Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group. J Am Heart Assoc. 2018 Jun 1;7(11):e008834. doi: 10.1161/JAHA.118.008834. No abstract available.
PubMed 29858368Ates B, Abraham L, Ercal N. Antioxidant and free radical scavenging properties of N-acetylcysteine amide (NACA) and comparison with N-acetylcysteine (NAC). Free Radic Res. 2008 Apr;42(4):372-7. doi: 10.1080/10715760801998638.
PubMed 18404536Nigwekar SU, Kandula P. N-acetylcysteine in cardiovascular-surgery-associated renal failure: a meta-analysis. Ann Thorac Surg. 2009 Jan;87(1):139-47. doi: 10.1016/j.athoracsur.2008.09.026.
PubMed 19101287Savluk OF, Guzelmeric F, Yavuz Y, Cevirme D, Gurcu E, Ogus H, Orki T, Kocak T. N-acetylcysteine versus Dopamine to Prevent Acute Kidney Injury after Cardiac Surgery in Patients with Preexisting Moderate Renal Insufficiency. Braz J Cardiovasc Surg. 2017 Jan-Feb;32(1):8-14. doi: 10.21470/1678-9741-2016-0028.
PubMed 28423123Kotlyar E, Keogh AM, Thavapalachandran S, Allada CS, Sharp J, Dias L, Muller D. Prehydration alone is sufficient to prevent contrast-induced nephropathy after day-only angiography procedures--a randomised controlled trial. Heart Lung Circ. 2005 Dec;14(4):245-51. doi: 10.1016/j.hlc.2005.06.007. Epub 2005 Oct 3.
PubMed 16360994Diaz-Sandoval LJ, Kosowsky BD, Losordo DW. Acetylcysteine to prevent angiography-related renal tissue injury (the APART trial). Am J Cardiol. 2002 Feb 1;89(3):356-8. doi: 10.1016/s0002-9149(01)02243-3. No abstract available.
PubMed 11809444
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of N-acetylcysteine to Prevent Acute Kidney Injury in Patients With Pre-existing Moderate Renal Insufficiency Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05555511
- Acronym / sponsor ID
- FMASU R 122/2022
- Conditions
- Kidney Injury, Acute
- Keywords
- N-acetylcysteine, Acute kidney injury, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 26 Jan 2023 (estimated)
- Study completion
- 26 Feb 2023 (estimated)
- First posted
- 27 Sep 2022 (actual)
- 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) or renal impairment is an established complication of cardiac surgery occurring with an incidence up to 30%, To date, no agent has conferred renal protection. Considerable interest has developed in the potential for Nacetylcysteine (NAC) to exert a renoprotective effect in patients undergoing cardiac surgery. Due to the beneficial effect of NAC on contrast nephropathy and its reported anti-inflammatory effects.
Detailed description
Acute kidney injury (AKI), is a well-known complication of cardiac surgery, with an incidence of up to 30% depending on the definition. AKI caused by cardiac surgery is the second most common cause of AKI in the intensive care unit and is a common and serious postoperative complication of cardiac surgery requiring cardiopulmonary bypass (CPB).
The pathogenesis of AKI after CPB is multifactorial, and is mostly due to hypo perfusion, reperfusion injury, activation of the systemic inflammatory response, and/or low cardiac output. Reperfusion will result in the formation of reactive oxygen species, resulting in injury to tissues.
The activation of the systemic inflammatory response is mostly due to the exposure of blood to the extracorporeal CPB circuit, resulting in the activation of the immune system, which is also mediated by the generation of reactive oxygen species. This results in increased recruitment of neutrophils, macrophages, and lymphocytes into the renal parenchyma, leading to AKI.
N-acetylcysteine (NAC) is well known for its antioxidant and free-radical scavenging properties, as well as its vasodilator properties. Its antioxidant properties enable it to prevent ischemic cell death, and as a free-radical scavenger, NAC mitigates the effect of increased reactive oxygen species caused by reperfusion. Hence, theoretically, NAC is able to counteract several mechanisms of kidney injury during cardiac surgery, namely, the systemic inflammatory response, free-radical injury, and ischemia.
In this study, we aimed to investigate if the perioperative use of acetylcysteine will prevent kidney injury after cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized using computer generated random series into two groups according to the used drug into: Group A: N-acetylcysteine group (23 Patients) Patients will receive N-acetylcysteine 600 mg intravenous(IV) every 12 hours 24 hours before surgery and will be continued for 48 hours after surgery. Group B : Standard (control) group (23 Patients) Patients will not receive N-Acetylcysteine and will receive standard care according to our institutional protocol.
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine group | Active comparator | Other: Control Group(23 Patients) Patients will recieve N-acetylcysteine 600 mg intravenous(IV) every 12 hours 24 hours before surgery and will be continued for 48 hours after surgery |
| Standard group | No intervention | –Patients will not receive N-Acetylcysteine and will receive standard care according to our institutional protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
- Pre-existing moderate renal insufficiency serum creatinine more than 1.5 mg/dL
Key exclusion criteria (9 listed)
- Patients on hemodialysis preoperatively
- History of renal transplantation
- IV contrast within 4 days prior to surgery
- Urgent/emergent surgery
- Preoperative hemodynamic instability (intra-aortic balloon pump support or vasoactive medications)
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 |
|---|---|---|
| Control GroupPatients will not receive N-Acetylcystiene and will receive standard care according to our institutional protocol | Other | N-acetylcysteine group |
Primary outcome
Serum Creatinine rise
Time frame: 7days
Creatinine increase >25% or ≥ 0.5 mg/dl above baseline
5 secondary outcomes
RRT
Time frame: 7 days
Length of ICU stay
Time frame: 3 days
Length of hospital stay
Time frame: 7 to 10 Days
Mortality
Time frame: 30 days
Adverse effects
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Background: PubMed 28515370Lee SH, Kim SJ, Kim HJ, Son JS, Lee R, Yoon TG. Acute Kidney Injury Following Cardiopulmonary Bypass in Children - Risk Factors and Outcomes. Circ J. 2017 Sep 25;81(10):1522-1527. doi: 10.1253/circj.CJ-17-0075. Epub 2017 May 17.
- Background: PubMed 24438155Schopka S, Diez C, Camboni D, Floerchinger B, Schmid C, Hilker M. Impact of cardiopulmonary bypass on acute kidney injury following coronary artery bypass grafting: a matched pair analysis. J Cardiothorac Surg. 2014 Jan 18;9:20. doi: 10.1186/1749-8090-9-20.
- Background: PubMed 22285125Dexter F. Duration of cardiopulmonary bypass and outcome. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):e19; author reply e19-20. doi: 10.1053/j.jvca.2011.12.012. Epub 2012 Jan 29. No abstract available.
- Background: PubMed 29858368Nadim MK, Forni LG, Bihorac A, Hobson C, Koyner JL, Shaw A, Arnaoutakis GJ, Ding X, Engelman DT, Gasparovic H, Gasparovic V, Herzog CA, Kashani K, Katz N, Liu KD, Mehta RL, Ostermann M, Pannu N, Pickkers P, Price S, Ricci Z, Rich JB, Sajja LR, Weaver FA, Zarbock A, Ronco C, Kellum JA. Cardiac and Vascular Surgery-Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group. J Am Heart Assoc. 2018 Jun 1;7(11):e008834. doi: 10.1161/JAHA.118.008834. No abstract available.
- Background: PubMed 18404536Ates B, Abraham L, Ercal N. Antioxidant and free radical scavenging properties of N-acetylcysteine amide (NACA) and comparison with N-acetylcysteine (NAC). Free Radic Res. 2008 Apr;42(4):372-7. doi: 10.1080/10715760801998638.
- Background: PubMed 19101287Nigwekar SU, Kandula P. N-acetylcysteine in cardiovascular-surgery-associated renal failure: a meta-analysis. Ann Thorac Surg. 2009 Jan;87(1):139-47. doi: 10.1016/j.athoracsur.2008.09.026.
- Background: PubMed 28423123Savluk OF, Guzelmeric F, Yavuz Y, Cevirme D, Gurcu E, Ogus H, Orki T, Kocak T. N-acetylcysteine versus Dopamine to Prevent Acute Kidney Injury after Cardiac Surgery in Patients with Preexisting Moderate Renal Insufficiency. Braz J Cardiovasc Surg. 2017 Jan-Feb;32(1):8-14. doi: 10.21470/1678-9741-2016-0028.
- Background: PubMed 16360994Kotlyar E, Keogh AM, Thavapalachandran S, Allada CS, Sharp J, Dias L, Muller D. Prehydration alone is sufficient to prevent contrast-induced nephropathy after day-only angiography procedures--a randomised controlled trial. Heart Lung Circ. 2005 Dec;14(4):245-51. doi: 10.1016/j.hlc.2005.06.007. Epub 2005 Oct 3.
- Background: PubMed 11809444Diaz-Sandoval LJ, Kosowsky BD, Losordo DW. Acetylcysteine to prevent angiography-related renal tissue injury (the APART trial). Am J Cardiol. 2002 Feb 1;89(3):356-8. doi: 10.1016/s0002-9149(01)02243-3. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Kidney Injury, Acute
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Mohamed A. Alhadidy principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Kidney Injury, Acute, run by Ain Shams 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 2 inclusion and 9 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 28 Dec 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A. Alhadidy, MD (00201005092648 ext. M., Mohamed_alaaeldin@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Creatinine rise (time frame: 7days). 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 NCT05555511, which also lists 9 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 28 Dec 2022.