Correction of acidosis in hemodialysis patients. Effects on protein metabolism, investigated by tracer technique and messenger-ribonucleic acid determination for ubuquitin and proteasome subunits.

ISRCTN	ISRCTN27844532
DOI	https://doi.org/10.1186/ISRCTN27844532
Protocol serial number	N/A
Sponsor	Karolinska University Hospital (Sweden)
Funders	Swedish Medical Research Council (ref: 11243 and 04210), Gambro AB, Baxter Inc., U.S. National Institutes of Health (R01 DK37175)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Erland Löfberg
Scientific

Karolinska University Hospital
Department of Renal Medicine
Solna
Stockholm
SE-171 76
Sweden

Phone	+46 (0)85 1773768
Email	erland.lofberg@karolinska.se

Primary study design	Interventional
Study design	Randomised, controlled, crossover design
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Metabolic acidosis stimulates muscle protein breakdown, correction of acidosis results in decreased protein breakdown.
Ethics approval(s)	Approved by the Ethics Committee of Karolinska Institute at Huddinge University Hospital on 11/01/1993, reference number: 196/96
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Muscle protein turnover
Key secondary outcome measure(s)	1. messenger-Ribonucleic Acid (mRNA) for ubuquitin and proteasome subunits 2. Plasma and muscle intracellular amino acid concentrations 3. Serum albumin
Completion date	31/12/1998

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	16
Key inclusion criteria	1. Clinically stable hemodialysis patients 2. >18 Years of age
Key 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
Date of first enrolment	01/04/1997
Date of final enrolment	31/12/1998

Karolinska University Hospital

Stockholm
SE-171 76
Sweden

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	01/09/2006		Yes	No