Comparative Effectiveness of 30%TSC and Heparin Lock Solution in Hemodialysis Catheters

NCT02563041 | Completed Phase 4

• 1 other identifier: UCPel
• Study Type: interventional
• Target: 179
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND: Central venous catheters (CVC) are the only option when hemodialysis is needed for patients without definitive vascular access. However, CVC use is associated with complications such as infection, thrombosis, and dysfunction, leading to higher mortality and expenditures. The aim of this study was to compare the effectiveness of 30% trisodium citrate (TSC30%) with heparin as CVC lock solution in preventing catheter-related bloodstream infections (CRBSI) and dysfunction in hemodialysis patients. METHODS: Randomized, double-blind controlled trial comparing the event-free survival of non-tunneled CVC locked with heparin or TSC30% in adult hemodialysis patients.

Conditions

Catheter Related Infection

Outcome Measures

Primary Outcomes (1)

• Catheter related bloodstream infection

  through study completion, an average of 2 years

Study Arms (2)

30%TSC

EXPERIMENTAL

After each hemodialysis (HD) session, the catheter lumens were flushed with 0.9% sodium chloride and locked with a volume of 30%TSC solution exactly equivalent to the catheter internal lumen.

Drug: 30% TSC

Heparin 5000 U/mL

ACTIVE COMPARATOR

After each hemodialysis (HD) session, the catheter lumens were flushed with 0.9% sodium chloride and locked with a volume of unfractionated sodium heparin 5000 U/mL solution exactly equivalent to the catheter internal lumen.

Drug: Heparin

Interventions

30% TSC DRUG

The patients were randomly assigned to have their catheter locked with either unfractionated sodium heparin 5000 U/mL or 30% trisodium citrate.

Also known as: 30% trisodium citrate

30%TSC

Heparin DRUG

The patients were randomly assigned to have their catheter locked with either unfractionated sodium heparin 5000 U/mL or 30% trisodium citrate.

Also known as: unfractionated sodium heparin 5000 U/mL

Heparin 5000 U/mL

Eligibility Criteria

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

You may qualify if:

• patients older than 18 years and
• with chronic or acute renal failure and
• requiring hemodialysis through a catheter.

You may not qualify if:

• patients admitted to the intensive care ward,
• receiving a tunneled catheter,
• patients with suspected heparin-induced thrombocytopenia,
• patients with allergy to heparin or TSC30%,
• patients with systemic or localized infection
• pregnant women

Sponsors & Collaborators

• Catholic University of Pelotas: lead

Related Publications (1)

• Correa Barcellos F, Pereira Nunes B, Jorge Valle L, Lopes T, Orlando B, Scherer C, Nunes M, Araujo Duarte G, Bohlke M. Comparative effectiveness of 30 % trisodium citrate and heparin lock solution in preventing infection and dysfunction of hemodialysis catheters: a randomized controlled trial (CITRIM trial). Infection. 2017 Apr;45(2):139-145. doi: 10.1007/s15010-016-0929-4. Epub 2016 Aug 29.

  PMID: 27573387 DERIVED

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

trans-sodium crocetinate; trisodium citrate; Heparin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Maristela Bohlke, MD, PhD

  Catholic University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 29, 2015
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 29, 2015

Record last verified: 2015-09