Plain English Summary
Background and study aims
In recent years much research has focused on the harmful effects of colloids used in patients hospitalized in the Intensive Care Unit (ICU). Only a few researchers have addressed the problem of the adverse effects of gelatin given during the surgical procedure. The optimal fluid therapy before surgery is intended to maintain a euvolemic state (the normal amount of body fluids) and replenish the possible fluid losses associated with surgery. It ensures the proper function of the circulatory system, optimal tissue perfusion and kidney function. Maintaining balanced fluid therapy is extremely difficult – the fluid type, volume, and rate of administration have to be adjusted to the type of surgery, its duration, preoperative fluid deficits, potential fluid losses, and the patients' other illnesses. The level of kidney injury molecule-1 (KIM-1) is low in healthy people and usually undetectable in the urine, but it increases markedly within hours following kidney injury. Therefore, the aim of this study is to investigate the effect of the gelatin solution used during a thyroidectomy (surgical removal of all or part of the thyroid gland) on kidney function using the urinary KIM-1 (uKIM-1) level.
Who can participate?
Patients aged 18-80 undergoing partial or total thyroidectomy
What does the study involve?
Participanys are randomly allocated to one of three groups. The patients from the first group A (experimental) receive 3% gelatin solution at a dose of 30 ml/kg body weight during the first hour of the procedure and then an isotonic multi-electrolyte solution at a dose of 15 ml/kg body weight/hour. The patients from the second group B (experimental) receive 3% gelatin solution at a dose of 15 ml/kg body weight during the first hour of the procedure and then the isotonic multi-electrolyte solution at a dose of 15 ml/kg body weight/hour. The patients from the third group C (control) receive an active-controlled intervention in the form of isotonic multi-electrolyte solution at a dose of 30 ml/kg body weight during the first hour of the procedure and then the isotonic multi-electrolyte at a dose of 15 ml/kg body weight/ hour. The following parameters are assessed: changes in the uKIM-1 level determined from urine samples; changes in the serum creatinine level determined from blood; and the level of selected vital signs.
What are the possible benefits and risks of participating?
The main general purpose of the study is prevention in terms of assuring proper kidney function and preventing kidney damage. All patients will be carefully monitored regarding possible adverse events such as allergic reaction to local anesthetics, technical difficulties of the blockade, or hematoma.
Where is the study run from?
1. 4th Military Hospital of Wroclaw (Poland)
2. Wroclaw Medical University (Poland)
When is the study starting and how long is it expected to run for?
April 2013 to December 2014
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Patrycja Leśnik
plesnik@4wsk.pl
Study website
Contact information
Type
Public
Contact name
Dr Patrycja Leśnik
ORCID ID
https://orcid.org/0000-0002-1457-9899
Contact details
Department of Anesthesiology and Intensive Care
4th Military Hospital of Wroclaw
Weigla 5
Wroclaw
50-981
Poland
+48 691 840 822
plesnik@4wsk.pl
Type
Scientific
Contact name
Dr Patrycja Leśnik
ORCID ID
https://orcid.org/0000-0002-1457-9899
Contact details
Department of Anesthesiology and Intensive Care
4th Military Hospital of Wroclaw
Weigla 5
50-981
Wroclaw
50-981
Poland
+48 691 840 822
plesnik@4wsk.pl
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Evaluation of the efficacy of 3% gelatin solution at a dose of 15 ml/kg versus a dose of 30 ml/kg body weight during the first hour of the thyroidectomy procedure on renal function based on urinary kidney injury molecule-1
Acronym
Study hypothesis
This study proves that the urinary kidney injury molecule-1 (uKIM-1) level could be an early and sensitive biomarker of kidney injury. Renal toxicity of the gelatin solution evaluated based on the uKIM-1 level, correlates with the administered volume of fluid. Restrictive fluid therapy with the 3% gelatin solution seems to be safe in patients without underlying kidney injury undergoing surgery.
Ethics approval(s)
Approved 23/05/2013, Bioethics Committee of the Wroclaw Medical University (Pasteura 1, 50-367 Wroclaw, Poland; +48 (0)71 784 10 14; bioetyka@umed.wroc.pl), ref: KB–283/2013
Study design
Multicenter interventional double-blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Renal function after thyroidectomy
Intervention
The project is performed in the Department of Anesthesiology and Intensive Care of the University Hospital of Wroclaw in Poland. Adult patients of both sexes qualified for planned thyroidectomy procedures are included in the study.
Patients are randomly assigned to three comparison groups who receive a different dose of 3% gelatin solution during the thyroidectomy procedure.
The patients from the first group A (experimental) receive an anesthesiologic intervention in the form of 3% gelatin solution (Geloplasma, Fresenius Kabi, Poland) at a dose of 30 ml/kg body weight during the first hour of the procedure and then the isotonic multi-electrolyte solution (Isolyte®, Fresenius Kabi, Poland) at a dose of 15 ml/kg body weight/hour.
The patients from the second group B (experimental) receive an anesthesiologic intervention in the form of 3% gelatin solution (Geloplasma®, Fresenius Kabi, Poland) at a dose of 15 ml/kg body weight during the first hour of the procedure and then the isotonic multi-electrolyte solution (Isolyte®, Fresenius Kabi, Poland) at a dose of 15 ml/kg body weight/hour.
The patients from the third group C (control) receive an active-controlled intervention in the form of isotonic multi-electrolyte Solution (Isolyte®, Fresenius Kabi, Warsaw, Poland) at a dose of 30 ml/kg body weight during the first hour of the procedure and then the isotonic multi-electrolyte solution (Isolyte®, Fresenius Kabi, Warsaw, Poland) at a dose of 15 ml/kg body weight/ hour.
The person performing the above-mentioned experimental procedures is the same anesthesiologist with at least 5 years of professional expertise.
In order to monitor the intensity of pain and possible verifying the treatment, the patient's documentation are routinely recorded: haemodynamic stability of the patient during the procedure (heart rate, blood pressure - data were obtained from the anaesthesia protocol), the intensity of pain, the need for the supply of coanalgesics and the number of complications and side effects.
Clinical parameters such as heart rate (continuous measurement), arterial blood saturation (continuous measurement), systolic, and diastolic pressure (measurement every 5 minutes) are collected from the anaesthesia protocol.
The creatinine level is measured and urine samples are taken to determine the initial concentration of uKIM-1 during a routine examination before the surgery and then 2 and 24 hours after the surgery. Urine samples of 15 ml are collected in urinary cups and centrifuged at 2000-3000 rpm for 20 minutes, and the supernatant is kept at -72 ºC. The quantitative determination of uKIM-1 is performed using an enzyme-linked immunoassay (ELISA) kit supplied by R&D Systems Inc. (Minneapolis, USA).
Intervention type
Procedure/Surgery
Primary outcome measure
1. Changes in the urinary kidney injury molecule-1 (uKIM-1) level determined from urine samples using an enzyme-linked immunoassay (ELISA) method at baseline, postoperative 2 hours, and 24 hours
2. Changes in the serum creatinine level determined from venous blood samples using laboratory methods at baseline, postoperative 2 hours, and 24 hours
Secondary outcome measures
The level of selected vital signs (heart rate, blood pressure, SaO₂) in the clinical monitoring of hemodynamic stability and anaesthesia effectiveness at baseline, intraoperative every 15 minutes of the procedure, and postoperative 15 minutes, 30 minutes, 45 minutes, and 60 minutes
Overall study start date
01/04/2013
Overall study end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients qualified for partial or total thyroidectomy
2. Age between 18-80 years old
3. ASA (American Society of Anesthesiologist Physical Status Classification System) score of I or II
4. The lack of contraindications for the administration of 3% gelatin solution (gelatin allergy)
5. The lack of blood coagulation disorders and the lack of allergy to anaesthetic agents
6. The obtained informed and written consent to participate in the study
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
80 Years
Sex
Both
Target number of participants
80
Total final enrolment
76
Participant exclusion criteria
1. Age < 18 years old and > 80 years old
2. ASA (American Society of Anesthesiologist Physical Status Classification System) score of III or IV
3. Impaired renal function prior to the surgery (serum creatinine >1.3 mg/dl)
4. Undergoing immunosuppressive therapy
5. Contraindications for the administration of 3% gelatin solution (gelatin allergy)
6. Coagulation disorders as a contraindication for anaesthesia
7. Allergy to local anaesthetics
8. The lack of obtained informed and written consent to participate in the study
Recruitment start date
01/02/2014
Recruitment end date
30/11/2014
Locations
Countries of recruitment
Poland
Study participating centre
4th Military Hospital of Wroclaw
Department of Anesthesiology and Intensive Care
Weigla 5
Wroclaw
50-981
Poland
Sponsor information
Organisation
4th Military Hospital of Wroclaw
Sponsor details
Department of Anesthesiology and Intensive Care
Weigla 5
Wroclaw
50-981
Poland
+48 71 712 89 39
reanimacja@4wsk.pl
Sponsor type
Hospital/treatment centre
Website
https://www.4wsk.pl/Kliniczny-Oddzial-Anestezjologii-i-Intensywnej-Terapii,13.html:o=49
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The research paper entitled "Effect of 3% gelatin solution on renal function based on urinary kidney injury molecule-1 in patients after thyroidectomy – a randomized controlled trial" is going to be submitted to be considered for publication in the Scientific Reports journal.
Intention to publish date
31/12/2021
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Patrycja Leśnik (patrycja.lesnik@gmail.com).
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/12/2021 | 10/12/2021 | Yes | No |