Serun Fluoride and Kidney Transplant

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

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

Study Overview

• Status: Completed
• Conditions: Kidney Transplant; Complications
• Intervention / Treatment: Drug: Sevoflurane; Drug: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• end stage renal disease

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sevoflurane; anesthesia was maintained with Sevoflurane 1-2%.	Drug: Sevoflurane; anesthesia was maintained with Sevoflurane 1-2%.; Other Names: Inhalational anesthetic
ACTIVE_COMPARATOR: isoflurane; anesthesia was maintained with isoflurane 1-2%.	Drug: Isoflurane; anesthesia was maintained with isoflurane 1-2%.; Other Names: Inhalational anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum fluoride	Serum inorganic fluoride	baseline before anesthesia
Serum fluoride	Serum inorganic fluoride	one hour postoperative
serum fluoride	Serum inorganic fluoride	6 hours postoperative
Serum fluoride	Serum inorganic fluoride	12 hours postoperative
Serum fluoride	Serum inorganic fluoride	24 hours postoperative
Serum fluoride	Serum inorganic fluoride	48 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine	kidney function	Baseline preoperative
Serum creatinine	kidney function	24 hours postoperative
Serum creatinine	kidney function	48 hours postoperative
Serum creatinine	kidney function	one week postoperative
creatinine clearance	kidney function	baseline before anesthesia
creatinine clearance	kidney function	24 hours postoperative
creatinine clearance	kidney function	48 hours postoperative
creatinine clearance	kidney function	one week postoperative
Urine output	kidney function	24 hours postoperative
Urine output	kidney function	48hours postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): October 1, 2017

Study Registration Dates

• First Submitted: December 2, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (ACTUAL): December 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Anesthetics; Sevoflurane; Isoflurane
• Other Study ID Numbers: IRB0000871242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No