Renal function and fluid turnover after infusion of saline and Ringer's acetate in elderly males

ISRCTN ISRCTN91152670
DOI https://doi.org/10.1186/ISRCTN91152670
Secondary identifying numbers 2008/804-31/2
Submission date
30/04/2014
Registration date
12/06/2014
Last edited
07/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
A non-cancerous enlarging of the prostrate is a common complaint in elderly men. Symptoms include difficulties in urinating, having to urinate more frequently, sudden urges to urinate and not being able to empty the bladder properly. In some cases, surgery is required where the excess prostate tissue is removed in a procedure called transurethral resection of the prostate. During the operation, fluids are used to wash out, or irrigate the bladder, and some of this fluid can enter the blood stream. In rare cases, this can cause the potentially fatal transurethral resection of the prostate syndrome. The aim of this study is to examine whether the fluid used today, saline, is the best choice or whether another fluid, Ringer’s acetate, should be used.

Who can participate?
Patients scheduled for prostate surgery (transurethral resection of the prostate) due to non-cancerous enlargement of the prostate at Södersjukhuset, Stockholm, and who have to pass urine through a catheter placed in their bladder.

What does the study involve?
Patients receive both fluids on different occasions during the surgery. Their kidney function is measured over 5 periods of 30 minutes each. Blood and urine samples are also taken for calculation of how the fluid is handled by the body.

What are the possible benefits and risks of participating?
There are no specific benefits associated with taking part in the study. There may be some temporary effects on kidney function due to narrowing of the blood vessels during surgery. Breathing problems may occur when the fluids are injected if the patient has undetected heart problems. There may also be some pain associated with placement of the venous cannulae (tube for administrating intravenous fluids)

Where is the study run from?
Department of Urology, Södersjukhuset, Sweden.

When is the study starting and how long is it expected to run for?
February 2013 to February 2015

Who is funding the study?
Södersjukhuset and Södertälje hospital, Sweden

Who is the main contact?
Professor Robert Hahn
r.hahn@telia.com

Contact information

Prof Robert Hahn
Scientific

Research Unit
Södertälje Sjukhus
Södertälje
152 86
Sweden

Phone +46 (0) 855024670
Email r.hahn@telia.com

Study information

Study designOpen randomized cross-over single-centre
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Patient information can be found at: http://roberthahn.se/Saline.pdf
Scientific titleGlomerular filtration rate and fluid volume kinetics of isotonic saline versus Ringer's acetate in males scheduled for transurethral resection of the prostate
Study acronymSIE (Saline In the Elderly)
Study objectivesTransurethral resection of the prostate is a surgical method of alleviating bladder outlet obstruction caused by prostatic hypertrophy, which is a common disease in elderly men. The operation is usually performed using isotonic saline as the irrigating solution. However, the irrigating medium might be absorbed by the patient and various amounts of the irrigating fluid thus be transported the the circulation. Saline is probably not the optimal solution to use, as balanced electrolyte solutions like Ringer's acetate show greater similarity to the composition of the extracellular fluid than saline. Importantly, glomerular filtration rate has been shown to be reduced in young volunteers.

We hypothesize that Ringer's acetate has a smaller effect on the glomerular filtration rate than isotonic saline when infused intravenously in patients scheduled for transurethral resection of the prostate. We also want to investigate, by using fluid kinetics, whether the body handles isotopic saline and Ringer's acetate differently in these primarily old males.
Ethics approval(s)Regional ethics committee of Stockholm on 11/06/2008, ref. 2008/804-31/2
Health condition(s) or problem(s) studiedTransurethral resection of the prostate
InterventionInfusion of two electrolyte isolations (saline and Ringer's acetate) on two different occasions. Continuous infusion of iohexol (an X-ray contrast medium that can be used to measure glomerular filtration rate), blood sampling and urine sampling on 12 occasions during each experiment.
Intervention typeProcedure/Surgery
Primary outcome measureGlomerular filtration rate, measured using continuous infusion of iohexol during five periods of 30 minutes each, starting 30 min after the study begins and 30 min after the fluid infusion is started
Secondary outcome measuresFluid volume kinetics based on blood and urine sampled during the last 3 hours of each experiment
Overall study start date14/02/2013
Completion date28/02/2015

Eligibility

Participant type(s)Patient
Age groupSenior
SexMale
Target number of participants12
Key inclusion criteriaPatients scheduled for transurethral resection of the prostate due to benign enlargement of the prostate at Södersjukhuset, Stockholm, who have an indwelling bladder catheter
Key exclusion criteriaPatients with severe renal disease (serum creatinine > 120) or heart disease (ASA group III)
Date of first enrolment14/02/2013
Date of final enrolment28/02/2015

Locations

Countries of recruitment

  • Sweden

Study participating centre

Research Unit
Södertälje
152 86
Sweden

Sponsor information

Södersjukhuset (Sweden)
Hospital/treatment centre

Department of Urology
Stockholm
118 83
Sweden

Website http://www.sodersjukhuset.se/

Funders

Funder type

Hospital/treatment centre

Södersjukhuset (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2016 Yes No

Editorial Notes

07/02/2018: Publication reference added.