Prospective randomised cross-over trial of regional citrate with heparin for anticoagulation and additional albumin prime in continuous venovenous haemofiltration in childre

Not Applicable

Recruiting

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

• Registration Number: ACTRN12608000462381
• Lead Sponsor: The Royal Childrens' Hospital Mebourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Any patient requiring Continuous Veno-venus Haemofiltration (CVVH) in the unit will be eligible for the trial. Parental consent will be obtained before the patient is recruited.

Exclusion Criteria

Patients with liver failure defined for the purpose of this trial as INR (international normalized ratio) >3 despite clotting factor replacement (these patients often have the problems of metabolizing heparin and citrate and more severe coagulopathy) or known sensitivity to heparin (i.e. heparin-induced thrombocytopenia) will be excluded from the trial. Patients with significant risk of bleeding (those with intra cranial, cerebral or pulmonary haemorrhage or stroke) will also be excluded, however, coagulopathic or thrombocytopenic patients without significant bleeding will be included.
If parental consent cannot be obtained or is not given the child will not participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the trial is haemofilter circuit duration, a TMP (Transmembrane Pressure) of 280mmHg determines end of circuit life. The data will be analysed using Kaplan-Meier plots, stratified log rank test and Cox proportional hazard regression of time to circuit failure, censoring circuits that are stopped for other reasons at the time of cessation.[A TMP (Transmembrane Pressure) of 280mmHg determines end of circuit life, circuits ceased for other reasons will be sensored]

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes to be analysed will be adverse events, such as excessive bleeding (assessed by medical and nursing staff by the bedside), thrombocytopenia, metabolic acidosis and hypocalcaemia (assessed by regular blood tests) using x2 tests.[Adverse events will be assessed as they occur and at a quarterly review (depending on numbers) for the duration of the trial.]