Citrate- Versus Acetate-Based Dialysate in Bicarbonate Haemodialysis: Consequences on Haemodynamics, Coagulation, Acid-Base Status and Electrolytes

NCT00718289 | Completed Phase 4

• 1 other identifier: 012008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Background: A concentrate for bicarbonate haemodialysis acidified with citrate instead of acetate has been marketed in the recent years. The small amount of citrate used (one-fifth of the concentration adopted in regional anticoagulation) protects against intradialyser clotting, minimally affecting the calcium concentration. The aim of this study is to compare the impact of a citrate- and acetate-based dialysate on systemic haemodynamics, coagulation, acid-base status, calcium balance and dialysis efficiency. Methods: In 25 patients, 375 dialysis sessions, we will compare acetate (A) with citrate dialysate with (C+) or without (C) calcium supplementation (0.25mmol/L) in a randomized single blind cross-over study. Systemic haemodynamics will be evaluated using pulse wave analysis systems. Coagulation, acid-base status, calcium balance and dialysis efficiency will be assessed using standard biochemical markers.

Conditions

Haemodialysis

Keywords

Citric acid; citrate; acetic acid; acetate; haemodialysis; calcium; hypotension; haemodynamics; Dialysate for Haemodialysis

Outcome Measures

Primary Outcomes (1)

• Consequences on systemic haemodynamics

  Study duration

Secondary Outcomes (1)

• Consequences on coagulation, acid-base status, calcium balance and dialysis efficiency

  Study duration

Study Arms (2)

Citrate

EXPERIMENTAL

Citrate dialysate for haemodialysis

Other: Citrate dialysate

Acetate

ACTIVE COMPARATOR

Acetate dialysate

Other: Acetate dialysate

Interventions

Citrate dialysate OTHER

dialysis fluid composition for Citrate (C) and Acetate (A): acetate \[3.0 mmol/L in A and 0.3 in C\], citrate \[0 mmol/L in A and 0.8 in C\]

Citrate

Acetate dialysate OTHER

dialysis fluid composition for Citrate (C) and Acetate (A): acetate \[3.0 mmol/L in A and 0.3 in C\], citrate \[0 mmol/L in A and 0.8 in C\]

Acetate

Eligibility Criteria

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

You may qualify if:

• chronic haemodialysis patients
• dialysed 3 to 4 hours three times a week, who were
• clinically stable and without intercurrent illnesses

You may not qualify if:

• intercurrent illnesses

Sponsors & Collaborators

• Ospedale Regionale di Locarno: lead
• Bichsel AG, Interlaken, Switzerland: collaborator

Study Sites (1)

Ospedale Regionale di Locarno

Locarno, Canton Ticino, 6600, Switzerland

Location

Related Publications (1)

• Gabutti L, Lucchini B, Marone C, Alberio L, Burnier M. Citrate- vs. acetate-based dialysate in bicarbonate haemodialysis: consequences on haemodynamics, coagulation, acid-base status, and electrolytes. BMC Nephrol. 2009 Mar 5;10:7. doi: 10.1186/1471-2369-10-7.

  PMID: 19265544 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luca Gabutti, MD

  Ospedale Regionale di Locarno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: March 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 18, 2008

Record last verified: 2008-07

Locations

CH (1)