Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/04/2014
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

Mr T Spyt

ORCID ID

Contact details

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 (0)116 258 4109

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123138282

Study information

Scientific title

Acronym

Study hypothesis

To examine potential methods of protecting the kidney during and immediately after heart surgery using cardiopulmonary bypass.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Cardiopulmonary bypass

Intervention

To examine potential methods of protecting the kidney during and immediately after heart surgery using cardiopulmonary bypass.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Determine whether perioperative low dose frusemide, dopamine or aminophylline would improve clinical and biochemical outcomes in adult patients, at increased risk of kidney dysfunction.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2003

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than 70 years
2. Pre-existing renal disease
3. Not on renal replacement therapy
4. Pre-operative serum creatinine greater than 130 umol/l
5. Type one diabetes mellitus

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

60 patients, 20 controls

Participant exclusion criteria

Only first time coronary artery surgery will be included

Recruitment start date

01/01/2003

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospitals of Leicester NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Departmental funding (UK)

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