A randomised controlled study comparing the effect of two different anticoagulation regimens on filter life during Continuous Renal Replacement Therapy (CRRT) – The Heparin Citrate (THC) Study

Phase 3

Completed

• Conditions: acute renal failure; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12609001079235
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

All must apply: a) the treating clinician believes that the patient requires CRRT for acute renal failure, b) the clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with citrate/calcium or heparin/protamine, d) informed consent has been obtained, or will be sought within 48h in those centres where delayed consent has been approved, e) the patient fulfils ONE of the following clinical criteria for initiating CRRT: (i) oliguria (urine output < 100ml/6hr) that has been unresponsive to fluid resuscitation measures. (ii) hyperkalemia ([K+] > 6.5 mmol/L), (iii) severe acidemia (pH < 7.2), (iv) urea > 25 mmol/L., (v) Creatinine >300 micromol/L, (vi) clinically significant organ oedema in the setting of acute renal failure (ARF) (eg: lung).

Exclusion Criteria

Any one may apply: a) expected short stay ICU (< 24hours), b) Age < 18 years, c) Acute or chronic liver failure, d) suspected ischaemic hepatitis, e) known allergy to protamine or heparin, f) suspected or confirmed heparin-induced thrombocytopenia, g) there is a
strong likelihood that the study treatment would not be continued in accordance with the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
functional filter life. The functional life of<br>the filter will be determined to be over when the circuit has clotted defined by the presence of one of the following: a) the transmembrane pressure across the filter is greater than 300 mmHg, b) there is visible clot in the circuit obstructing blood flow, c) the blood pump is unable to rotate due to obstruction by clot in the membrane or circuit. The end of the functional filter life will be determined by intensive care nursing staff not associated with the running of the trial.[time to event in hours]

Secondary Outcome Measures

Name	Time	Method
cytokines. Serum will be frozen and batch analysed later for interleukins 6, 8 and 10 (at least).[0, 24, 72 hours];Units of red cells transfused. This will be determined from the blood bank transfusion record of administered packed red cells..[Count. This is defined as the number of packed red cells administered during the entire intensive care unit (ICU) admission.];duration of continuous renal replacement therapy (CRRT)[time in hours. This is measured at the final conclusion of the continuous renal replacement therapy (CRRT). CRRT may finally conclude upon recovery of renal function, discharge from ICU, or commencement of intermittent haemodialysis.];duration of ICU admission[time in hours. This is measured from the time of admission to the intensive care unit until the time of discharge from the intensive care unit.];mortality[at hospital discharge]