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Completed

NCT Number: NCT03373266

Serun Fluoride and Kidney Transplant

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • end stage renal disease

Exclusion criteria

-

Treatment and study plan

Sevoflurane

Drug

anesthesia was maintained with Sevoflurane 1-2%.

Other names: Inhalational anesthetic

Isoflurane

Drug

anesthesia was maintained with isoflurane 1-2%.

Other names: Inhalational anesthetic

Primary outcomes

  1. Serum fluoride

    Time frame: baseline before anesthesia

    Serum inorganic fluoride

  2. Serum fluoride

    Time frame: one hour postoperative

    Serum inorganic fluoride

  3. serum fluoride

    Time frame: 6 hours postoperative

    Serum inorganic fluoride

  4. Serum fluoride

    Time frame: 12 hours postoperative

    Serum inorganic fluoride

  5. Serum fluoride

    Time frame: 24 hours postoperative

    Serum inorganic fluoride

  6. Serum fluoride

    Time frame: 48 hours postoperative

    Serum inorganic fluoride

Secondary outcomes

  1. Serum creatinine

    Time frame: Baseline preoperative

    kidney function

  2. Serum creatinine

    Time frame: 24 hours postoperative

    kidney function

  3. Serum creatinine

    Time frame: 48 hours postoperative

    kidney function

  4. Serum creatinine

    Time frame: one week postoperative

    kidney function

  5. creatinine clearance

    Time frame: baseline before anesthesia

    kidney function

  6. creatinine clearance

    Time frame: 24 hours postoperative

    kidney function

  7. creatinine clearance

    Time frame: 48 hours postoperative

    kidney function

  8. creatinine clearance

    Time frame: one week postoperative

    kidney function

  9. Urine output

    Time frame: 24 hours postoperative

    kidney function

  10. Urine output

    Time frame: 48hours postoperative

    kidney function

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 14, 2017
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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