Perioperative Use of NAC to Prevent AKI in Patients With Pre-existing Moderate Renal Insufficiency Following Cardiac Surgery

NCT05555511 | Unknown DMC

• 1 other identifier: FMASU R 122/2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Kidney Injury, Acute

Keywords

N-acetylcysteine; Acute kidney injury; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Serum Creatinine rise

  Creatinine increase \>25% or ≥ 0.5 mg/dl above baseline

  7days

Secondary Outcomes (5)

• RRT

  7 days

• Length of ICU stay

  3 days

• Length of hospital stay

  7 to 10 Days

• Mortality

  30 days

• Adverse effects

  2 days

Study Arms (2)

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

Other: Control Group

Standard group

NO INTERVENTION

Patients will not receive N-Acetylcysteine and will receive standard care according to our institutional protocol

Interventions

Control Group OTHER

Patients will not receive N-Acetylcystiene and will receive standard care according to our institutional protocol

N-acetylcysteine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
• Pre-existing moderate renal insufficiency serum creatinine more than 1.5 mg/dL

You may not qualify if:

• 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;
• Planned deep-hypothermic-circulatory-arrest
• known or suspected allergy to NAC
• Patient Refusal.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Cardiothoracic Academy, Ain Shams University Hospitals

Cairo, 11566, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 28515370 BACKGROUND

• Schopka 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.

  PMID: 24438155 BACKGROUND

• Dexter 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.

  PMID: 22285125 BACKGROUND

• Nadim 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.

  PMID: 29858368 BACKGROUND

• Ates 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.

  PMID: 18404536 BACKGROUND

• Nigwekar 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.

  PMID: 19101287 BACKGROUND

• Savluk 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.

  PMID: 28423123 BACKGROUND

• Kotlyar 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.

  PMID: 16360994 BACKGROUND

• Diaz-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.

  PMID: 11809444 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mohamed A. Alhadidy

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A. Alhadidy, MD

CONTACT

00201005092648; Mohamed_alaaeldin@med.asu.edu.eg

Adel M. Alansary, MD

CONTACT

00201223954877; adelalansary@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: August 26, 2022
• Primary Completion: January 26, 2023
• Study Completion: February 26, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)