Effect of 3% gelatin solution on kidney function in patients after thyroid gland removal

Category Primary study
Registry of TrialsISRCTN registry
Year 2021
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 pos CONDITION: Renal function after thyroidectomy ; Surgery PRIMARY OUTCOME: ; 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: 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 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
Epistemonikos ID: 611373c128b749c39d0a235087d7c82ebeec36ab
First added on: Aug 25, 2024