Renal Failure ChronicNCT03778944
Enhancing Renal Graft Function During Donor Anesthesia
A study testing Mannitol infusion, Dopamine infusion and Adequate hydration in people with Renal Failure Chronic and Transplant;Failure,Kidney, run by Nazmy Edward Seif at 1 site in Egypt.
Trial summary
Renal transplantation is now recognized as the treatment of choice for patients with end-stage renal disease. An optimum anesthetic regimen should enhance the function and perfusion of the transplanted kidney. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia
- What is being tested?
- Mannitol infusion, Dopamine infusion and Adequate hydration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- end-stage renal disease, for living-donor kidney transplantation
Who cannot join
- severe cardiac or hepatic dysfunction
- coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al-Ainy Hospital, Cairo University
Cairo
Nazmy E Seif, MD, 01227400808 ext. +2, drnazmyseif@yahoo.com
Ahmed M Elbadawy, MD, 01064249076 ext. +2, elbadawyahmed89@yahoo.com
About this study
Official title: Renal Graft Functional Enhancement During Donor Anesthesia: A Comparative Study of 3 Modalities
Renal transplantation is now recognized as the treatment of choice for patients with end-stage renal disease. An optimum anesthetic regimen should enhance the function and perfusion of the transplanted kidney. The aim of this study is to assess \& compare the effectiveness of 3 different modalities in this respect: Mannitol, Dopamine and adequate hydration.
- Conditions
- Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia
- Being tested
- Mannitol infusion, Dopamine infusion, Adequate hydration
- Keywords
- Mannitol, Dopamine, Perfusion, Renal graft donor, Anesthesia
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannitol infusionProcedure or surgery
Infusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes.
Dopamine infusionProcedure or surgery
Infusion of Dopamine at a dose of 4 microg/kg/min to the renal graft donor after induction of anesthesia till ligation of the renal artery.
Adequate hydrationProcedure or surgery
Infusion of Ringer Acetate at a rate of 15 ml/kg/hr to the renal graft donor after induction of anesthesia till ligation of the renal artery.
| Study group | Role | What they receive |
|---|---|---|
| M group | Active comparator | Mannitol infusion Receives: Procedure: Mannitol infusion |
| D group | Active comparator | Dopamine infusion Receives: Procedure: Dopamine infusion |
| C group | Active comparator | Adequate hydration Receives: Procedure: Adequate hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative creatinine clearance
Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Dec 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using computer \& sealed envelope randomization, patients are assigned to receive either Mannitol \[M group; n=20\], Dopamine \[D group; n=20\] or adequate hydration \[C group; n=20\]
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Nazmy E Seif, MD, Study chair, Kasr Al-Ainy Hospital, Cairo UniversityAhmed M Elbadawy, MD, Study director, Kasr Al-Ainy Hospital, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778944
- Sponsor's protocol ID
- RGFEDDA
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2018
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Graft Functional Enhancement During Donor Anesthesia: A Comparative Study of 3 Modalities
- ClinicalTrials.gov ID
- NCT03778944
- Acronym / sponsor ID
- RGFEDDA
- Conditions
- Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia
- Keywords
- Mannitol, Dopamine, Perfusion, Renal graft donor, Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Renal transplantation is now recognized as the treatment of choice for patients with end-stage renal disease. An optimum anesthetic regimen should enhance the function and perfusion of the transplanted kidney. The aim of this study is to assess \& compare the effectiveness of 3 different modalities in this respect: Mannitol, Dopamine and adequate hydration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Using computer \& sealed envelope randomization, patients are assigned to receive either Mannitol [M group; n=20], Dopamine [D group; n=20] or adequate hydration [C group; n=20]
| Arm | Type | Receives |
|---|---|---|
| M group | Active comparator | Procedure: Mannitol infusionMannitol infusion |
| D group | Active comparator | Procedure: Dopamine infusionDopamine infusion |
| C group | Active comparator | Procedure: Adequate hydrationAdequate hydration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- end-stage renal disease, for living-donor kidney transplantation
Key exclusion criteria (2 listed)
- severe cardiac or hepatic dysfunction
- coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mannitol infusionInfusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes. | Procedure or surgery | M group |
| Dopamine infusionInfusion of Dopamine at a dose of 4 microg/kg/min to the renal graft donor after induction of anesthesia till ligation of the renal artery. | Procedure or surgery | D group |
| Adequate hydrationInfusion of Ringer Acetate at a rate of 15 ml/kg/hr to the renal graft donor after induction of anesthesia till ligation of the renal artery. | Procedure or surgery | C group |
Primary outcome
Post-operative creatinine clearance
Time frame: 7 days
Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nazmy E Seif, MD study chair
Kasr Al-Ainy Hospital, Cairo University
Ahmed M Elbadawy, MD study director
Kasr Al-Ainy Hospital, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mannitol infusion, Dopamine infusion and Adequate hydration in people with Renal Failure Chronic and Transplant;Failure,Kidney, run by Nazmy Edward Seif 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 2 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazmy E Seif, MD (01227400808 ext. +2, drnazmyseif@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative creatinine clearance (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.