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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73266049
Enrollment
80
Registered
2021-04-08
Start date
2014-02-01
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal function after thyroidectomy Surgery

Interventions

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 proced

Sponsors

4th Military Hospital of Wroclaw
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1. Age 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Poland

Contacts

Public ContactPatrycja Lesnik
plesnik@4wsk.pl+48 691 840 822

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026