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

Perioperative Use of N-acetylcysteine to Prevent Acute Kidney Injury in Patients With Pre-existing Moderate Renal Insufficiency Following Cardiac Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05555511
Enrollment
46
Registered
2022-09-27
Start date
2022-08-26
Completion date
2023-02-26
Last updated
2022-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Injury, Acute

Keywords

N-acetylcysteine, Acute kidney injury, Cardiac surgery

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.

Interventions

OTHERControl Group

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum Creatinine rise7daysCreatinine increase \>25% or ≥ 0.5 mg/dl above baseline

Secondary

MeasureTime frameDescription
RRT7 daysNeed for Renal Replacement Therapy
Length of ICU stay3 daysLength of stay in the ICU in days
Length of hospital stay7 to 10 DaysLength of stay in hospital in days
Mortality30 daysMortality rate
Adverse effects2 daysOccurrence of NAC adverse effects as (bronchospasm, urticaria, facial edema, nausea/vomiting).

Countries

Egypt

Contacts

Primary ContactMohamed A. Alhadidy, MD
Mohamed_alaaeldin@med.asu.edu.eg00201005092648
Backup ContactAdel M. Alansary, MD
adelalansary@med.asu.edu.eg00201223954877

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026