Condition category
Surgery
Date applied
30/04/2014
Date assigned
12/06/2014
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Robert Hahn

ORCID ID

Contact details

Research Unit
Södertälje Sjukhus
Södertälje
152 86
Sweden
+46 (0) 855024670
r.hahn@telia.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2008/804-31/2

Study information

Scientific title

Glomerular filtration rate and fluid volume kinetics of isotonic saline versus Ringer's acetate in males scheduled for transurethral resection of the prostate

Acronym

SIE (Saline In the Elderly)

Study hypothesis

Transurethral 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

Regional ethics committee of Stockholm on 11/06/2008, ref. 2008/804-31/2

Study design

Open randomized cross-over single-centre

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://roberthahn.se/Saline.pdf

Condition

Transurethral resection of the prostate

Intervention

Infusion 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 type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Glomerular 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 measures

Fluid volume kinetics based on blood and urine sampled during the last 3 hours of each experiment

Overall trial start date

14/02/2013

Overall trial end date

28/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Patients scheduled for transurethral resection of the prostate due to benign enlargement of the prostate at Södersjukhuset, Stockholm, who have an indwelling bladder catheter

Participant type

Patient

Age group

Senior

Gender

Male

Target number of participants

12

Participant exclusion criteria

Patients with severe renal disease (serum creatinine > 120) or heart disease (ASA group III)

Recruitment start date

14/02/2013

Recruitment end date

28/02/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Research Unit
Södertälje
152 86
Sweden

Sponsor information

Organisation

Södersjukhuset (Sweden)

Sponsor details

Department of Urology
Stockholm
118 83
Sweden

Sponsor type

Hospital/treatment centre

Website

http://www.sodersjukhuset.se/

Funders

Funder type

Hospital/treatment centre

Funder name

Södersjukhuset (Sweden)

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

Publication citations

Additional files

Editorial Notes