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Serun Fluoride and Kidney Transplant

NCT ID: NCT03373266

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Kidney Transplant; Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sevoflurane

anesthesia was maintained with Sevoflurane 1-2%.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

anesthesia was maintained with Sevoflurane 1-2%.

isoflurane

anesthesia was maintained with isoflurane 1-2%.

Group Type ACTIVE_COMPARATOR

Isoflurane

Intervention Type DRUG

anesthesia was maintained with isoflurane 1-2%.

Interventions

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Sevoflurane

anesthesia was maintained with Sevoflurane 1-2%.

Intervention Type DRUG

Isoflurane

anesthesia was maintained with isoflurane 1-2%.

Intervention Type DRUG

Other Intervention Names

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Inhalational anesthetic Inhalational anesthetic

Eligibility Criteria

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Inclusion Criteria

* end stage renal disease

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrady S Ibrahim, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelrady S Ibrahim, M.D.

Role: PRINCIPAL_INVESTIGATOR

assiut university faculty of medicine

Locations

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Assiut university faculty of medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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

Reference Type BACKGROUND
PMID: 8050420 (View on PubMed)

Other Identifiers

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IRB0000871242

Identifier Type: -

Identifier Source: org_study_id