Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/03/2006
Date assigned
03/07/2006
Last edited
26/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Erland Löfberg

ORCID ID

Contact details

Karolinska University Hospital
Department of Renal Medicine
Solna
Stockholm
SE-171 76
Sweden
+46 (0)85 1773768
erland.lofberg@karolinska.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Metabolic acidosis stimulates muscle protein breakdown, correction of acidosis results in decreased protein breakdown.

Ethics approval

Approved by the Ethics Committee of Karolinska Institute at Huddinge University Hospital on 11/01/1993, reference number: 196/96

Study design

Randomised, controlled, crossover design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

End-stage renal failure

Intervention

Adjustments of acid-base balance - in each patient, protein turnover will be measured twice, at a standard bicarbonate concentration of <19 mmol/l and >25 mmol/l respectively, with an interval between the two measurements (random order) of 3-4 weeks. The acid-base status will be altered by adjusting the dose of bicarbonate (oral and/or via dialysis) and protein turnover will be measured when the predialysis bicarbonate level have been low or normal for at least one week.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Muscle protein turnover

Secondary outcome measures

1. messenger-Ribonucleic Acid (mRNA) for ubuquitin and proteasome subunits
2. Plasma and muscle intracellular amino acid concentrations
3. Serum albumin

Overall trial start date

01/04/1997

Overall trial end date

31/12/1998

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinically stable hemodialysis patients
2. >18 Years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

16

Participant exclusion criteria

1. Clinically obvious malnutrition
2. Ongoing infection
3. Diabetes mellitus
4. Untreated congestive heart failure
5. Treatment with corticosteroids or other immunosuppressive agents

Recruitment start date

01/04/1997

Recruitment end date

31/12/1998

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska University Hospital
Stockholm
SE-171 76
Sweden

Sponsor information

Organisation

Karolinska University Hospital (Sweden)

Sponsor details

Department of Clinical Science
Karolinska Institute
Huddinge
Stockholm
SE-14186
Sweden
+46 (0)85 8582656
anders.alvestrand@ki.se

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Swedish Medical Research Council (ref: 11243 and 04210)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Gambro AB

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Baxter Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

U.S. National Institutes of Health (R01 DK37175)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16931215

Publication citations

  1. Results

    Löfberg E, Gutierrez A, Anderstam B, Wernerman J, Bergström J, Price SR, Mitch WE, Alvestrand A, Effect of bicarbonate on muscle protein in patients receiving hemodialysis., Am. J. Kidney Dis., 2006, 48, 3, 419-429, doi: 10.1053/j.ajkd.2006.05.029.

Additional files

Editorial Notes