Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05285709 |
| Other study ID # |
BIAKOR |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2022 |
| Est. completion date |
November 2023 |
Study information
| Verified date |
April 2022 |
| Source |
Medical University of Warsaw |
| Contact |
Przemyslaw Bolewski |
| Phone |
0048225021721 |
| Email |
klinanest1[@]wum.edu.pl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Surgical treatment of hip fracture may be complicated by acute kidney injury. The aim of this
study is to investigate whether the investigators can find a better biomarker than creatinine
to recognize this problem at an earlier stage.
Description:
Extensive orthopedic surgical procedures may have many postoperative complications. One of
those, sometimes overlooked, is acute kidney injury. Classically defined by KDIGO criteria as
an increase in creatinine concentration, may go by unnoticed due to a late peak in serum
concentration of this marker. There is still need for "nephrological troponin" which could
easily and with a low margin of doubt identify acute kidney injury.
The investigators have planned a double-center study, in cooperation with the 'Department of
Anesthesiology and Intensive Therapy with the Postoperative Subdivision' of the 'Samodzielny
Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP' in Otwock, concentrating on measuring
concentration of biomarkers known to indicate acute kidney injury in different situations:
Proenkephalin (PENK), Dickkopf-3 (DKK3), circular RNA (circRNA), Liver-type Fatty
Acid-binding Protein (L-FABP), Netrin-1, semaphorin 3a, Tissue Inhibitor of Matrix
Metalloproteinase-2 (TIMP-2), Insulin-like Growth Factor-binding Protein 7 (IGFBP-7),
Retinol-binding Protein-4 (RBP-4) aiming to find a marker, or group of markers that would
allow recognition of renal injury at an early stage to help minimize the effect.
Patients aged at least 18 years, with a hip fracture undergoing, either hip alloplasty, or
internal fixation, after providing informed consent, will be included. Patients with end
stage renal disease will be excluded. Blood and urine samples will be collected at 5 points
of time: 1 - after admission to the operating ward, 2 - following surgery, before leaving the
operating ward, 3 - on the 1st postoperative day, 4 - on the 2nd postoperative day, 5 - on
the 5th postoperative day, or the day the patient leaves hospital, whichever is first.
Additionally patients who will be able to cooperate will have a renal resistive index
measured using ultrasonography.
Blood collected from patients, not longer than 8 hours after collection will be tested for
PENK concentration (Spingotec GmbH, Berlin, Germany), then plasma obtained from this sample
after centrifuging will be frozen together with centrifugated samples of urine in -80 degrees
Celsius till analysis.
Additionally, if the concentration of PENK is elevated, the same sample will be tested after
8, 12 and 24 hours of staying at room temperature, to define stability of the test from blood
sampling till measurement.
30 days after surgery, an attempt to contact the patient or his/her family is going to be
made, to check if the patient has developed need for renal replacement therapy or has
required hospitalisation due to kidney dysfunction together with a 30 day mortality
evaluation.
