Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients

NCT00563342 | Terminated Phase 2

• 1 other identifier: CHU-0027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis. The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter. As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)

Conditions

End Stage Renal Failure, Hemodialysis

Keywords

Ethanol, lock solution, infection

Outcome Measures

Primary Outcomes (1)

• The catheters dysfunction rate

  as partial or complete occlusion or infection associated with dialysis catheter

Secondary Outcomes (1)

• The dialysis quality is also examined (urea reduction rate, total ultrafiltration)

  as partial or complete occlusion or infection associated with dialysis catheter

Interventions

Ethanol DRUG

Examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis

Eligibility Criteria

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

You may qualify if:

• Patients of both genders, over 18 years,
• Chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days,
• Written informed consent
• Social security

You may not qualify if:

• Antibiotic therapy during selection phase,
• Partial or complete catheter occlusion during selection phase,
• Venous pressure at dialysis connection \> 300 mmHg,
• Known allergy to ethanol,
• Severe co-morbidity
• Acute or chronic infectious disease
• Evolutive neoplasia,
• Scheduled surgery

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Lacarin

Clermont-Ferrand, 63000, France

Location

Related Publications (1)

• Coupez E, Timsit JF, Ruckly S, Schwebel C, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Darmon M, Boyer A, Azoulay E, Bouadma L, Lautrette A, Souweine B. Guidewire exchange vs new site placement for temporary dialysis catheter insertion in ICU patients: is there a greater risk of colonization or dysfunction? Crit Care. 2016 Jul 30;20(1):230. doi: 10.1186/s13054-016-1402-6.

  PMID: 27473868 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Infections

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Bertrand Souweine, Pr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2007
• First Posted: November 26, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 8, 2008

Record last verified: 2008-10

Locations

FR (1)