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

Primary Purpose

Kidney Injury, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Control Group
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Injury, Acute focused on measuring N-acetylcysteine, Acute kidney injury, Cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cardiothoracic Academy, Ain Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

N-acetylcysteine group

Standard group

Arm Description

(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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

RRT
Need for Renal Replacement Therapy
Length of ICU stay
Length of stay in the ICU in days
Length of hospital stay
Length of stay in hospital in days
Mortality
Mortality rate
Adverse effects
Occurrence of NAC adverse effects as (bronchospasm, urticaria, facial edema, nausea/vomiting).

Full Information

First Posted
September 22, 2022
Last Updated
December 26, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05555511
Brief Title
Perioperative Use of NAC to Prevent AKI in Patients With Pre-existing Moderate Renal Insufficiency Following Cardiac Surgery
Official Title
Perioperative Use of N-acetylcysteine to Prevent Acute Kidney Injury in Patients With Pre-existing Moderate Renal Insufficiency Following Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
January 26, 2023 (Anticipated)
Study Completion Date
February 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Injury, Acute
Keywords
N-acetylcysteine, Acute kidney injury, Cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine group
Arm Type
Active Comparator
Arm Description
(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
Arm Title
Standard group
Arm Type
No Intervention
Arm Description
Patients will not receive N-Acetylcysteine and will receive standard care according to our institutional protocol
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Patients will not receive N-Acetylcystiene and will receive standard care according to our institutional protocol
Primary Outcome Measure Information:
Title
Serum Creatinine rise
Description
Creatinine increase >25% or ≥ 0.5 mg/dl above baseline
Time Frame
7days
Secondary Outcome Measure Information:
Title
RRT
Description
Need for Renal Replacement Therapy
Time Frame
7 days
Title
Length of ICU stay
Description
Length of stay in the ICU in days
Time Frame
3 days
Title
Length of hospital stay
Description
Length of stay in hospital in days
Time Frame
7 to 10 Days
Title
Mortality
Description
Mortality rate
Time Frame
30 days
Title
Adverse effects
Description
Occurrence of NAC adverse effects as (bronchospasm, urticaria, facial edema, nausea/vomiting).
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump. Pre-existing moderate renal insufficiency serum creatinine more than 1.5 mg/dL Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A. Alhadidy, MD
Phone
00201005092648
Ext
M.
Email
Mohamed_alaaeldin@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Adel M. Alansary, MD
Phone
00201223954877
Email
adelalansary@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A. Alhadidy
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiothoracic Academy, Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
University President
Phone
+2026847819
Email
gd.research@asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Adel Alansary
First Name & Middle Initial & Last Name & Degree
Ahmed Eldemerdash
First Name & Middle Initial & Last Name & Degree
Mohamed Alhadidy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28515370
Citation
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.
Results Reference
background
PubMed Identifier
24438155
Citation
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.
Results Reference
background
PubMed Identifier
22285125
Citation
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.
Results Reference
background
PubMed Identifier
29858368
Citation
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.
Results Reference
background
PubMed Identifier
18404536
Citation
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.
Results Reference
background
PubMed Identifier
19101287
Citation
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.
Results Reference
background
PubMed Identifier
28423123
Citation
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.
Results Reference
background
PubMed Identifier
16360994
Citation
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.
Results Reference
background
PubMed Identifier
11809444
Citation
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.
Results Reference
background

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

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