Early RRT in AKI After Cardiac Surgery

NCT05175053 | Terminated DMC

• 1 other identifier: D-2107-213-1239
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

Acute kidney injury (AKI) is one of the major complications after cardiac surgery that may affects 20% to 40% of patients according to the definitions. Also, AKI after cardiac surgery is associated with high morbidity and mortality, with eight-fold increase in the odds ratio of death when renal replacement therapy (RRT) is required. However the indication and the optimal timing of RRT initiation are still controversial. We hypothesized that a strategy of early initiation of RRT would result in a lower risk of surgical mortality than a standard strategy in post cardiac surgery patients with AKI of Kidney Disease: Improving Global Outcomes (KDIGO) classification stage 2 (serum creatinine, 2.0 times the baseline level; urine output, \<0.5mL/kg/h for 6 or more hours).

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Post Cardiac Surgery; Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with operative mortality

  any death, regardless of cause, occurring (1) within 30 days after surgery in or out of the hospital, and (2) after 30 days during the same hospitalization subsequent to the operation

  at postoperative 30 days

Secondary Outcomes (8)

• Overall survival

  at postoperative 90 days

• Number of participants with cardiovascular mortality

  at postoperative 90 days

• Number of participants with renal replacement therapy dependency

  at postoperative 90 days

• Number of participants with major adverse kidney events (MAKE)

  at postoperative 90 days

• Number of participants with renal replacement therapy related morbidity

  at postoperative 90 days

Study Arms (2)

Early RRT group

EXPERIMENTAL

Patients who will undergo renal replacement therapy (RRT) within 6 hours of diagnosis of stage 2 acute kidney injury (AKI).

Other: Renal replacement therapy

Delayed RRT group

ACTIVE COMPARATOR

Patients who will undergo renal replacement therapy (RRT) if one of the absolute indications for RRT is present.

Other: Best medical management

Interventions

Best medical management OTHER

The best medical management continues until the patient meets absolute indication of renal replacement therapy

Delayed RRT group

Renal replacement therapy OTHER

Continuous renal replacement therapy using continuous venovenous hemodiafiltration (CVVHDF)

Early RRT group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients within 7 days after cardiac surgery
• Acute kidney injury (AKI) described as Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 (urine output \<0.5mL/kg/h for ≥6h or 2-fold increase in serum creatinine compared with baseline)

You may not qualify if:

• previous renal replacement therapy
• AKI secondary to obstructive nephropathy
• previous kidney transplantation

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Renal Replacement Therapy

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)

Therapeutics

Study Officials

• Ho Young Hwang, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 3, 2022
• Study Start: December 24, 2021
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)