A Study on the Efficacy and Safety of Continuous Renal Replacement Therapy (CVVHDF) Using a Commercial Citrate-containing Replacement Fluid (Prismocitrate 18/0)

NCT01921816 | Completed

• 1 other identifier: UW 12-173
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to examine the efficacy and safety of using a new citrate containing commercially available solutions (Prismocitrate 18/0) as the regional citrate anticoagulation in continuous renal replacement therapy for critically ill patients.

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

• filter lifespan

  filter lifespan will be recorded as the time duration from commencement of renal replacement therapy till filter clotted or therapy ended

  up to 4 days

Secondary Outcomes (2)

• metabolic and electrolyte control

  up to 4days

• bleeding/transfusion requirement

  up to 4 days

Study Arms (1)

Prismocitrate 18/0

OTHER

citrate-containing replacement solution (Prismocitrate 18/0, Gambro) will be administered at pre-filter port during continuous hemodiafiltration, for the purpose as replacement solution and anticoagulation

Device: Prismocitrate 18/0, Prism0cal

Interventions

Prismocitrate 18/0, Prism0cal DEVICE

Subjects on continuous hemodiafiltration will ordinarily receive heparin as the anticoagulation. In our study, regional citrate anticoagulation with Prismacitrate is used to replace heparin. Citrate has been shown in study to be safer than heparin with reduced bleeding risk

Also known as: Prismocitrate 18/0 (replacement solution), Prism0cal (dialysate), Gambro

Prismocitrate 18/0

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient requires CRRT as treatment for renal failure, as decided by the attending physician
• The patient fulfils at least one of the following clinical criteria for initiating CRRT:
• According to the RIFLE criteria, (11) patients satisfying the "injury" criteria (increase creatinine by 2 fold or urine output\<0.5ml/kg/hr for 12hr) will be considered for CRRT
• Hyperkalemia (\[K+\] \> 6.5 mmol/L).
• Severe acidemia (pH \< 7.2).
• Urea \> 25 mmol/liter.
• Clinically significant organ oedema in the setting of ARF.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Adult Intensive Care unit, Queen Mary Hospital

Hong Kong, 852, Hong Kong

Location

Related Publications (3)

• Oudemans-van Straaten HM, Kellum JA, Bellomo R. Clinical review: anticoagulation for continuous renal replacement therapy--heparin or citrate? Crit Care. 2011 Jan 24;15(1):202. doi: 10.1186/cc9358.

  PMID: 21345279 BACKGROUND

• Leung AK, Shum HP, Chan KC, Chan SC, Lai KY, Yan WW. A retrospective review of the use of regional citrate anticoagulation in continuous venovenous hemofiltration for critically ill patients. Crit Care Res Pract. 2013;2013:349512. doi: 10.1155/2013/349512. Epub 2013 Jan 28.

  PMID: 23424680 BACKGROUND

• Shum HP, Chan KC, Yan WW. Regional citrate anticoagulation in predilution continuous venovenous hemofiltration using prismocitrate 10/2 solution. Ther Apher Dial. 2012 Feb;16(1):81-6. doi: 10.1111/j.1744-9987.2011.01001.x. Epub 2011 Oct 3.

  PMID: 22248200 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 13, 2013
• Study Start: May 1, 2012
• Primary Completion: August 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

HK (1)