- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05175053
Early RRT in AKI After Cardiac Surgery
Early Application of Renal-Replacement Therapy in Patients With Acute Kidney Injury After Cardiac Surgery: A Multicenter Randomized Controlled Trial
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This trial was designed as a multi-center randomized, controlled trial to recruit 202 patients who develop acute kidney injury (AKI) described as Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 (serum creatinine, 2.0 times the baseline level; urine output, <0.5mL/kg/h for 6 or more hours) after cardiac surgery. Patients were randomized in a 1:1 ratio to 1 of the 2 treatment groups (Early vs. Delayed renal replacement therapy (RRT)) using a computerized system.
Sample size determination : power calculation were performed based on the primary end point (operative mortality). The expected operative mortality in the control group with delayed initiation of RRT was 55% based on the literature. Differences between treatment groups were to be detected with a power of 80%, if the operative mortality of with early initiation of RRT was 35% or less. The expected treatment effect of 20% was calculated on the mortality differences between early and delayed RRT reported in previous studies. A required sample size for the final analysis was 101 patients per treatment group, 202 patients in total (level of significance, α = 0.05; type II error, β= 0.02; potential dropouts= 5%).
Early RRT was initiated within 6 hours of diagnosis of stage 2 AKI.
Delayed RRT was initiated if any one of the following absolute indications for RRT is present
- serum urea level higher than 100mg/dL and/or with uremic encephalopathy
- serum potassium level higher than 6mmol/L and/or with electrocardiography abnormalities
- urine production lower than 0.3mL/kg/hr for 24 hours
- pH of 7.15 or less and/or severe hypotension due to metabolic acidosis
- organ edema in the presence of AKI resistant to diuretic treatment.
The primary end point is operative mortality (described as 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).
The secondary end points included 90 day overall survival, cardiovascular mortality, RRT dependence, and major adverse kidney events (MAKE), adverse events related to RRT or vascular access, duration of mechanical ventilator support and intensive care unit stay, and hospital length of stay.
RRT delivery
: Once RRT was initiated, both groups were treated using continuous venovenous hemodiafiltration (CVVHDF) with identical settings. Initial target dose of hemodiafiltration was 25 to 50mL/kg/hr depends on the decision of attending physician and further adjusted according to the metabolic needs of the patient. Replacement fluid was delivered into the extracorporeal circuit before the filter with a ratio of dialysate to replacement fluid of 1:1. Blood flow was maintained between 100 to 250mL/min. Regional anticoagulation with nafamostat (dosage 20-50mg/hr) was used to prevent circuit clotting if necessary.
RRT was discontinued if renal recovery defined by urine output (>1mL/Kg/hr for 8 hours or more or >1000mL/24h without diuretics; >2000mL/24h with diuretics) and creatinine clearance (>20mL/min) occurred.
If cessation criteria were not fulfilled after 7 days, conversion to intermittent hemodialysis would be considered.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seongnam, Korea, Republic of
- Recruiting
- Seoul National University Bundang Hospital
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- previous renal replacement therapy
- AKI secondary to obstructive nephropathy
- previous kidney transplantation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early RRT group
Patients who will undergo renal replacement therapy (RRT) within 6 hours of diagnosis of stage 2 acute kidney injury (AKI).
|
Continuous renal replacement therapy using continuous venovenous hemodiafiltration (CVVHDF)
|
Active Comparator: Delayed RRT group
Patients who will undergo renal replacement therapy (RRT) if one of the absolute indications for RRT is present.
|
The best medical management continues until the patient meets absolute indication of renal replacement therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with operative mortality
Time Frame: at postoperative 30 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: at postoperative 90 days
|
overall survival
|
at postoperative 90 days
|
Number of participants with cardiovascular mortality
Time Frame: at postoperative 90 days
|
Any death related to cardiac events, including sudden death during follow-up
|
at postoperative 90 days
|
Number of participants with renal replacement therapy dependency
Time Frame: at postoperative 90 days
|
Number of participants who still needs renal replacement therapy at 90 days after operation.
|
at postoperative 90 days
|
Number of participants with major adverse kidney events (MAKE)
Time Frame: at postoperative 90 days
|
MAKE indicates the composite of death, need of renal replacement therapy, and persistent renal dysfunction.
|
at postoperative 90 days
|
Number of participants with renal replacement therapy related morbidity
Time Frame: at postoperative 90 days
|
adverse events related to renal replacement therapy (RRT) or vascular access for RRT.
|
at postoperative 90 days
|
Duration of mechanical ventilation
Time Frame: at postoperative 30 days
|
duration of mechanical ventilator support
|
at postoperative 30 days
|
Duration of intensive care unit stay
Time Frame: at postoperative 30 days
|
duration of intensive care unit stay
|
at postoperative 30 days
|
Hospital length of stay
Time Frame: at postoperative 30 days
|
hospital length of stay
|
at postoperative 30 days
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-2107-213-1239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
Beni-Suef UniversityCairo UniversityRecruitingAKI - Acute Kidney InjuryEgypt
-
University Hospital MuensterBaxter Healthcare CorporationCompletedAcute Kidney Injury (AKI)Spain, France, United States, Turkey, Germany, Egypt, Italy, Libyan Arab Jamahiriya, Malta, North Macedonia, Palestinian Territory, occupied, Russian Federation, Saudi Arabia, Slovenia
-
Chinese PLA General HospitalBeijing Tsinghua Changgeng HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Chinese PLA General HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Ain Shams UniversityRecruiting
-
Astellas Pharma IncCompleted
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
Clinical Trials on Renal replacement therapy
-
Petrovsky National Research Centre of SurgeryRecruitingCardiovascular Diseases | Multiple Organ Failure | Renal Failure AcuteRussian Federation
-
Nanjing Medical UniversityRecruiting
-
University Hospital, Clermont-FerrandCompletedAdults Receiving Renal Replacement TherapyFrance
-
US Department of Veterans AffairsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Inje UniversityCompletedEnd-stage Renal DiseaseKorea, Republic of
-
Radovan UvizlUnknown
-
Chulalongkorn UniversityCompletedAcute Renal FailureThailand
-
AKI Critical Care Research FoundationUnknownContinuous Renal Replacement TherapyUnited States
-
Sunnybrook Health Sciences CentreDialysis Solutions Inc.Completed
-
University of ThessalyRecruitingSepsis | Septic Shock | Renal Replacement Therapy | Aminoglycoside ToxicityGreece