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Kidney Transplant; ComplicationsPhase 2NCT03373266

Serun Fluoride and Kidney Transplant

A Phase 2 study testing Sevoflurane and Isoflurane in people with Kidney Transplant; Complications, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Kidney Transplant; Complications
What is being tested?
Sevoflurane and Isoflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
Oct 2015to Oct 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • end stage renal disease

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut university faculty of medicine

    Asyut

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Sevoflurane, Isoflurane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SevofluraneDrug

    Also called Inhalational anesthetic

    anesthesia was maintained with Sevoflurane 1-2%.

  • IsofluraneDrug

    Also called Inhalational anesthetic

    anesthesia was maintained with isoflurane 1-2%.

Study groups in NCT03373266
Study groupRoleWhat they receive
SevofluraneActive comparatoranesthesia was maintained with Sevoflurane 1-2%.
Receives: Drug: Sevoflurane
isofluraneActive comparatoranesthesia was maintained with isoflurane 1-2%.
Receives: Drug: Isoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum fluoride

    Serum inorganic fluoride

    Measured: baseline before anesthesia

  2. Serum fluoride

    Serum inorganic fluoride

    Measured: one hour postoperative

  3. serum fluoride

    Serum inorganic fluoride

    Measured: 6 hours postoperative

  4. Serum fluoride

    Serum inorganic fluoride

    Measured: 12 hours postoperative

  5. Serum fluoride

    Serum inorganic fluoride

    Measured: 24 hours postoperative

  6. Serum fluoride

    Serum inorganic fluoride

    Measured: 48 hours postoperative

Secondary outcomes (10)

  1. Serum creatinine

    kidney function

    Measured: Baseline preoperative

  2. Serum creatinine

    kidney function

    Measured: 24 hours postoperative

  3. Serum creatinine

    kidney function

    Measured: 48 hours postoperative

  4. Serum creatinine

    kidney function

    Measured: one week postoperative

  5. creatinine clearance

    kidney function

    Measured: baseline before anesthesia

  6. creatinine clearance

    kidney function

    Measured: 24 hours postoperative

  7. creatinine clearance

    kidney function

    Measured: 48 hours postoperative

  8. creatinine clearance

    kidney function

    Measured: one week postoperative

  9. Urine output

    kidney function

    Measured: 24 hours postoperative

  10. Urine output

    kidney function

    Measured: 48hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2017
  2. Study startOct 2015
  3. Primary completionAug 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03373266
Sponsor's protocol ID
IRB0000871242
Status last verified
Dec 2017
First submitted
2 Dec 2017
Last updated
14 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

    PubMed 8050420

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sevoflurane and Isoflurane in people with Kidney Transplant; Complications, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum fluoride (time frame: baseline before anesthesia). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03373266, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.

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