Condition category
Surgery
Date applied
04/05/2014
Date assigned
12/06/2014
Last edited
12/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.forskningsstod.sll.se/Ansokan/start.asp

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

Publication citations

Additional files

Editorial Notes