NCT03373266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

1.8 years

First QC Date

December 2, 2017

Last Update Submit

December 13, 2017

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (10)

  • Serum creatinine

    Baseline preoperative

  • Serum creatinine

    24 hours postoperative

  • Serum creatinine

    48 hours postoperative

  • Serum creatinine

    one week postoperative

  • creatinine clearance

    baseline before anesthesia

  • +5 more secondary outcomes

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

anesthesia was maintained with Sevoflurane 1-2%.

Drug: Sevoflurane

isoflurane

ACTIVE COMPARATOR

anesthesia was maintained with isoflurane 1-2%.

Drug: Isoflurane

Interventions

SevofluraneDRUG

anesthesia was maintained with Sevoflurane 1-2%.

Also known as: Inhalational anesthetic
Sevoflurane
IsofluraneDRUG

anesthesia was maintained with isoflurane 1-2%.

Also known as: Inhalational anesthetic
isoflurane

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • end stage renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

Related Publications (1)

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

    PMID: 8050420BACKGROUND

MeSH Terms

Interventions

SevofluraneIsoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Abdelrady S Ibrahim, M.D.

    assiut university faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 2, 2017

First Posted

December 14, 2017

Study Start

October 1, 2015

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

December 14, 2017

Record last verified: 2017-12

Locations

EG(1)