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Serun Fluoride and Kidney Transplant

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03373266
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Implication of Serum Fluoride Level Caused by Sevoflurane Versus Isoflurane Anesthesia Upon Renal Function After Kidney Transplantation.
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum fluoride [baseline before anesthesia]

      Serum inorganic fluoride

    2. Serum fluoride [one hour postoperative]

      Serum inorganic fluoride

    3. serum fluoride [6 hours postoperative]

      Serum inorganic fluoride

    4. Serum fluoride [12 hours postoperative]

      Serum inorganic fluoride

    5. Serum fluoride [24 hours postoperative]

      Serum inorganic fluoride

    6. Serum fluoride [48 hours postoperative]

      Serum inorganic fluoride

    Secondary Outcome Measures

    1. Serum creatinine [Baseline preoperative]

      kidney function

    2. Serum creatinine [24 hours postoperative]

      kidney function

    3. Serum creatinine [48 hours postoperative]

      kidney function

    4. Serum creatinine [one week postoperative]

      kidney function

    5. creatinine clearance [baseline before anesthesia]

      kidney function

    6. creatinine clearance [24 hours postoperative]

      kidney function

    7. creatinine clearance [48 hours postoperative]

      kidney function

    8. creatinine clearance [one week postoperative]

      kidney function

    9. Urine output [24 hours postoperative]

      kidney function

    10. Urine output [48hours postoperative]

      kidney function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • end stage renal disease
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university faculty of medicine Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Abdelrady S Ibrahim, M.D., assiut university faculty of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Abdelrady S Ibrahim, MD, Assistant professor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03373266
    Other Study ID Numbers:
    • IRB0000871242
    First Posted:
    Dec 14, 2017
    Last Update Posted:
    Dec 14, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Anesthetics
    Sevoflurane
    Isoflurane

    Study Results

    No Results Posted as of Dec 14, 2017