Serun Fluoride and Kidney Transplant

Phase 2

Completed

• Conditions: Kidney Transplant; Complications
• Interventions: Drug: Sevoflurane; Drug: Isoflurane

• Registration Number: NCT03373266
• Lead Sponsor: Assiut University

Brief Summary

Our primary goal is to investigate any hidden burden upon the grafted kidney from the increase of serum fluoride resulted from sevoflurane, versus isoflurane.

Detailed Description

Eighty patients with end stage renal failure undergoing living donor kidney transplant under general anesthesia were included in this study, by using an open (non-blinded) study design, patients were randomly assigned to two groups, 15 patients in each. Randomization was done through computer generated random tables. Isoflurane group; anesthesia was maintained with isoflurane 1-2%. Sevoflurane group; anesthesia was maintained with Sevoflurane 1-2%.

A peripheral intravenous access was secured in the hand opposite to the functioning fistula and induction of anesthesia was done with propofol 2mg/kg, neuromuscular blockade was maintained with atracurium 0.6mg/kg and all patients were intubated and ventilated to maintain end-tidal carbon dioxide (ETCO2) concentration between 30-40 mmHg. Anaesthesia was maintained with 1-2% isoflurane (isoflurane group) or 1-2% sevoflurane (sevoflurane group) with fresh gas flow of 2 L/min. In both groups inhalational anesthetic was delivered in an air-oxygen mixture of 1:1 ratio. Analgesia was maintained with fentanyl 1µg/kg/hr. Mannitol and sodium bicarbonate was given immediately before reperfusion (de-clamping of renal artery). Intraoperative monitoring included heart rate, noninvasive blood pressure, oxygen saturation, ETCO2, ECG and central venous line was placed in the right or left internal jugular vein depending upon the presence of dialysis catheter. Hemodynamic target include: mean arterial pressure of \> 80mmHg, CVP between 10-15 mm Hg to optimize cardiac output and renal blood flow.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2017-08
• Study Completion: 2017-10
• Status Verified: 2017-12
• Study First Submitted: 2017-12-02
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Study First Posted: 2017-12-14
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• end stage renal disease

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	anesthesia was maintained with Sevoflurane 1-2%.
isoflurane	Isoflurane	anesthesia was maintained with isoflurane 1-2%.

Primary Outcome Measures

Name	Time	Method
Serum fluoride	48 hours postoperative	Serum inorganic fluoride
serum fluoride	6 hours postoperative	Serum inorganic fluoride

Secondary Outcome Measures

Name	Time	Method
Serum creatinine	one week postoperative	kidney function
creatinine clearance	one week postoperative	kidney function
Urine output	48hours postoperative	kidney function

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt