Serun Fluoride and Kidney Transplant

Kidney Transplant; Complications Clinical Trial

Official title:

Implication of Serum Fluoride Level Caused by Sevoflurane Versus Isoflurane Anesthesia Upon Renal Function After Kidney Transplantation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373266
• Other study ID #: IRB0000871242
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2017
• Last updated: December 13, 2017
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• end stage renal disease

Exclusion Criteria:

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

Drug:
• Sevoflurane
anesthesia was maintained with Sevoflurane 1-2%.
• Isoflurane
anesthesia was maintained with isoflurane 1-2%.

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Burchardi H, Kaczmarczyk G. The effect of anaesthesia on renal function. Eur J Anaesthesiol. 1994 May;11(3):163-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum fluoride	Serum inorganic fluoride	baseline before anesthesia
Primary	Serum fluoride	Serum inorganic fluoride	one hour postoperative
Primary	serum fluoride	Serum inorganic fluoride	6 hours postoperative
Primary	Serum fluoride	Serum inorganic fluoride	12 hours postoperative
Primary	Serum fluoride	Serum inorganic fluoride	24 hours postoperative
Primary	Serum fluoride	Serum inorganic fluoride	48 hours postoperative
Secondary	Serum creatinine	kidney function	Baseline preoperative
Secondary	Serum creatinine	kidney function	24 hours postoperative
Secondary	Serum creatinine	kidney function	48 hours postoperative
Secondary	Serum creatinine	kidney function	one week postoperative
Secondary	creatinine clearance	kidney function	baseline before anesthesia
Secondary	creatinine clearance	kidney function	24 hours postoperative
Secondary	creatinine clearance	kidney function	48 hours postoperative
Secondary	creatinine clearance	kidney function	one week postoperative
Secondary	Urine output	kidney function	24 hours postoperative
Secondary	Urine output	kidney function	48hours postoperative