Investigating Different Anticoagulants for Renal Replacement Therapy (RICH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02669589|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2016
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Drug: Heparin Drug: Citrate||Phase 4|
Purpose of clinical trial:
To evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.
Patient population: critically ill patients with acute kidney injury requiring renal replacement therapy.
Anticoagulation of the extracorporeal circuit is required in continuous RRT (CRRT). To this date, it is not clear which anticoagulant should be used for CRRT. Regional citrate anticoagulation (RCA) for CRRT in critically ill patients with AKI prolongs filter life span and reduces 90-day all cause mortality by approximately 8% (from 48% to 40%) compared to systemic heparin anticoagulation for CRRT
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||638 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Regional Citrate Versus Systemic Heparin Anticoagulation for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||February 2020|
Active Comparator: heparin anticoagulation
Systemic anticoagulation of the continuous renal replacement therapy with heparin.
Dose will be titrated to maintain aPTT (activated partial thromboplastin time) between 45-60s)
Experimental: citrate anticoagulation
Regional anticoagulation of the continuous renal replacement therapy with citrate.
Target posthemofilter ionized calcium level: 0.25-0.35 mmol/l
- CRRT-filter life span in hours [ Time Frame: during continuous renal replacement therapy up to 1 year ]It will be reported how long the filter will be used during CRRT
- Overall survival in a 90day follow-up period [ Time Frame: 90 days ]
- ICU length of stay in days [ Time Frame: up to 1 year ]The primary ICU stay will be documented.
- Hospital length of stay in days [ Time Frame: up to 1 year ]
- duration of renal replacement therapy [ Time Frame: 1 year ]within 1 year after randomization
- Bleeding complication [ Time Frame: intraoperative ]
- Number of patients with administration of red blood cells [ Time Frame: intraoperative ]
- Rate of infection [ Time Frame: during primary ICU stay up to 1 year ]
- Major adverse kidney events [ Time Frame: day 28, 60, 90 and after 1 year after start of CRRT ]
- Complications of therapy [ Time Frame: intraoperative ]
- Recovery of renal function [ Time Frame: day 28, 60, 90 and 1 year after start of CRRT ]The recovery of renal function will be defined as composite endpoint consisting of lack of dialysis dependency and serum creatinine level no more than 0.5 mg/dl above the baseline value)
- Number of participants with hemodialysis [ Time Frame: day 28, 60, 90 and 1 year after start of CRRT ]
- Mortality [ Time Frame: day 28, 60 and 1-year ]
- SOFA Scores (Sepsis-related Organ Failure Assessment score) [ Time Frame: day 1-14, 21 and 28 during ICU stay ]
- serum creatinine level in mg/dL [ Time Frame: Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation ]
- plasma urea concentration in mg/dl [ Time Frame: Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation ]
- glomerular filtration rate [ Time Frame: Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669589
|Study Chair:||Alexander Zarbock, MD||University Hospital Muenster|