Plain English Summary
Background and study aims
Acute kidney injury, where the kidneys suddenly become unable to function properly, is a serious complication that can occur during hip fracture surgery in the elderly. This could be due to a number of factors, and this study aims to see whether it may be due to poor fluid intake by the patient (preoperative dehydration) and the choice of infusion fluid (crystalloid or hyperoncotic colloid) used during the operation.
Who can participate?
Adults aged between 70-90 years with a hip fracture and scheduled for surgery.
What does the study involve?
Each patient is randomly chosen to receive either crystalloid or hyperoncotic colloid at the start of the operation. Urine and blood samples will also be taken three times during the course of the day of the surgery.
What are the possible benefits and risks of participating?
All patients will benefit from having their blood circulation monitored using a non-invasive apparatus called the Nexfin. Hyperoncotic colloid can cause fluid to collect in the lungs of susceptible patients, but this is minimized by giving only a small amount of the fluid and also by doing so at the point when the anaesthesia is given; this causes the blood vessels to widen (vasodilation)
Where is the study run from?
Södertälje Hospital (Sweden)
When is study starting and how long is it expected to run for?
September 2014 to September 2015
Who is funding the study?
Stockholm County Council (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
House 18
Södertälje Hospital
Södertälje
15286
Sweden
+46 (0) 855024670
r.hahn@telia.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2014/497-31/4
Study information
Scientific title
Kidney injury during hip fracture surgery: a randomized study between crystalloid and colloid fluid and the influence of preoperative dehydration
Acronym
KIHF
Study hypothesis
Kidney injury that develops during acute hip fracture surgery can be related to preoperative dehydration and/or to the use of albumin 20% for plasma volume support
Ethics approval
Regional Ethics Committee of Stockholm, 02/04/2014, ref. 2014/497-31/4
Study design
Randomized double-blinded trial
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/PatientinfoAlb.pdf
Condition
Hip fracture surgery
Intervention
Patients are randomized to receive either 100 ml of Ringer´s acetate solution or 100 ml of 20% albumin during the induction of anaesthesia. Blood and urine sampling is performed on three occasions on the day of surgery.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Changes in urine markers of kidney injury (NGAL, microglobulin, albumin, creatinine and erythrocytes). Urine sampled at baseline and 4 hours after surgery has ended
Secondary outcome measures
1. The effect of albumin and crystalloid fluid on the colloid osmotic pressure, measured at baseline, the beginning of the surgery, and 4 hours after the surgery
2. Surgical complications, measured when the patient leaves the hospital
Overall trial start date
01/09/2014
Overall trial end date
30/09/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males and females with hip fracture who are planned for acute surgery
2. Age range 70-90 years
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
40 patients, based on that some increase in kidney injury markers occur in half of our patients (pilot study)
Participant exclusion criteria
1. Kidney disease
2. Serious heart failure (NYHA class III)
3. Those undergoing surgery under general anaesthesia
4. Poor understanding of the Swedish language
Recruitment start date
01/09/2014
Recruitment end date
30/09/2015
Locations
Countries of recruitment
Sweden
Trial participating centre
Research Unit, House 18
Södertälje
15286
Sweden
Sponsor information
Organisation
Stockholm County Council (Sweden)
Sponsor details
Hantverkargatan 45
Box 22550
Stockholm
10422
Sweden
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockholm County Council (Sweden), grant 20130297
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