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

Not Applicable

Completed

• Conditions: Renal function after thyroidectomy; Surgery

• Registration Number: ISRCTN73266049
• Lead Sponsor: 4th Military Hospital of Wroclaw

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34880372/ (added 10/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-12-31
• Study Start: 2021-04-08
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Changes in the serum creatinine level determined from venous blood samples using laboratory methods at baseline, postoperative 2 hours, and 24 hours<br>

Secondary Outcome Measures

Name	Time	Method
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