Additional identifiers
EudraCT number
2012-000942-36
ClinicalTrials.gov number
Protocol/serial number
13238
Study information
Scientific title
Are prophylactic antibiotics necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial
Acronym
PoWAR
Study hypothesis
Around two-thirds of all kidney transplants in the UK are performed using kidneys from living kidney donors; these are indviduals who have volunteered to donate one of their kidneys. Every attempt is made to minimise the risk of complications in these patients, who do not have any need to undergo surgery.
We know that a significant number (10-15%) of these patients will have infections (such as infections of their surgical wound, urinary infections or chest infections) after surgery. These infections may lead to a longer time spent in hospital, re-attendance at the hospital, GP or local Emergency department after discharge and a longer recovery time. Most donors are working and a delay in returning to work is important to them. Infections may cause significant discomfort and anxiety. Costs are increased (threefold) due to the longer hospital stay. A single dose of antibiotics given at the start of surgery is often used to prevent surgical site infections. However, whether this is beneficial for living donors has not been tested. Patients undergoing bowel surgery for example, are usually ill (donors are healthy) and bowel surgery is regarded as a 'contaminated' operation, due to the bacteria within the gut. Living kidney donation however may not involve potential contamination with bacteria. If antibiotics are used unnecessarily, consequences include side effects, such as diarrhoea and allergic reactions (which can be serious), the spread of resistance to antibiotics, and an extra cost. We are therefore proposing a trial which will compare the risk of infections, side effects, hospital stay and costs in those who receive a dose of antibiotics and those who receive a placebo (which would be an injection of salt water). The patients will be randomised by a computer to one or other treatment, and patients will be followed for one month after surgery. We expect that the findings will be easy to implement across the UK for living donors.
Ethics approval
12/LO/0877
Study design
Randomised; Interventional;
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders
Intervention
A single intravenous dose (1.2g) of the IMP (or placebo) will be given at induction of anaesthesia.
Intervention type
Drug
Phase
Not Applicable
Drug names
Primary outcome measure
The primary outcome measure will be a composite endpoint of any infection; this will include surgical site infections as well as urinary tract, respiratory and any other infections, within 30 days of surgery.
Secondary outcome measures
1. Ultrasonic evidence of wound healing
2. Length of hospital stay
3. Readmission rates
4. Antibiotic associated side effects (including diarrhoea and allergic reactions), return to work and normal activities
5. Quality of life and relative costs
Overall trial start date
01/01/2013
Overall trial end date
30/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included
2. Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice
3. Women of child-bearing age taking adequate contraception will be included
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 284; UK Sample Size: 284
Participant exclusion criteria
1. Patients with a known allergy to penicillin or other antibiotics
2. Patients with MRSA colonisation
3. Participation in another investigational study within the previous 90 days
4. Pregnant or breastfeeding women
Recruitment start date
01/01/2013
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Renal Unit
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list