The KIdney during surgery for Hip Fracture repair in elderly patients: possible injury due to poor fluid intake and the choice of infusion fluid during the surgery
| ISRCTN | ISRCTN17236125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17236125 |
- Submission date
- 04/05/2014
- Registration date
- 12/06/2014
- Last edited
- 23/02/2023
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Research Unit, House 18
Södertälje Hospital
Södertälje
15286
Sweden
| Phone | +46 (0) 855024670 |
|---|---|
| r.hahn@telia.com |
Study information
| Study design | Randomized double-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://roberthahn.se/PatientinfoAlb.pdf |
| Scientific title | Kidney injury during hip fracture surgery: a randomized study between crystalloid and colloid fluid and the influence of preoperative dehydration |
| Study acronym | KIHF |
| Study objectives | 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(s) | Regional Ethics Committee of Stockholm, 02/04/2014, ref. 2014/497-31/4 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2014 |
| Completion date | 30/09/2015 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 40 patients, based on that some increase in kidney injury markers occur in half of our patients (pilot study) |
| Key inclusion criteria | 1. Males and females with hip fracture who are planned for acute surgery 2. Age range 70-90 years |
| Key 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 |
| Date of first enrolment | 01/09/2014 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
15286
Sweden
Sponsor information
Government
Hantverkargatan 45
Box 22550
Stockholm
10422
Sweden
| Website | http://www.forskningsstod.sll.se/Ansokan/start.asp |
|---|---|
"ROR" |
https://ror.org/02zrae794 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | observational substudy data examining relationships between potential markers of poor outcome, such as kidney injury and mortality, in hip fracture patients | 03/06/2015 | 23/02/2023 | Yes | No |
Editorial Notes
23/02/2023: Publication reference uploaded.
07/02/2018: Principal investigator (Prof Robert Hahn) informed that the trial was never performed due to a lack of interested colleagues.
