Anesthesia MorbidityNCT03306914
Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients
A study testing Albumin resuscitation, Hydroxyethylstarch resuscitation and Albumin 5% in people with Anesthesia Morbidity, run by Cairo University at 1 site in Egypt.
Trial summary
In this study we try to review the possible effects when using modern hydroxyethylstarch solutions 6 % versus albumin 5% during living donor renal transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia Morbidity
- What is being tested?
- Albumin resuscitation, Hydroxyethylstarch resuscitation and Albumin 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2017to 1 Feb 2019
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- end stage renal disease, for living donor renal transplantation
Who cannot join
- severe cardiac or hepatic dysfunction, re-transplantation, coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Volume Expansion for Optimum Renal Transplant Surgery: Albumin Versus Starch
In this study we try to review the possible effects when using modern hydroxyethylstarch solutions 6 % versus albumin 5% during living donor renal transplantation.
- Conditions
- Anesthesia Morbidity
- Being tested
- Albumin resuscitation, Hydroxyethylstarch resuscitation, Albumin 5%, Hydroxyethylstarch 6%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin resuscitationOther
Albumin 5% is used as the intra-operative colloid
Hydroxyethylstarch resuscitationOther
Hydroxyethyl starch 6% is used as the intra-operative colloid
Albumin 5%Drug
Also called Albumin
Infusion of Albumin 5% intra-operatively
Hydroxyethylstarch 6%Drug
Also called Tetraspan
Infusion of Hydroxyethylstarch 6% intra-operatively
| Study group | Role | What they receive |
|---|---|---|
| Albumin group | Active comparator | Albumin resuscitation Albumin 5% Receives: Other: Albumin resuscitation; Drug: Albumin 5% |
| Hydroxyethylstarch group | Experimental | Hydroxyethylstarch resuscitation Hydroxyethylstarch 6% Receives: Other: Hydroxyethylstarch resuscitation; Drug: Hydroxyethylstarch 6% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of complications
Increased creatinine and/or need for dialysis
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 posted11 Oct 2017
- Study start15 Oct 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kareem, Cairo University
- Investigators
- Ahmed Kareem, Study director, Kasr Al-Ainy Hospiral, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306914
- Sponsor's protocol ID
- Albumin versus starch
- Status last verified
- Jan 2020
- First submitted
- 6 Oct 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Volume Expansion for Optimum Renal Transplant Surgery: Albumin Versus Starch
- ClinicalTrials.gov ID
- NCT03306914
- Acronym / sponsor ID
- Albumin versus starch
- Conditions
- Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 11 Oct 2017 (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.
In this study we try to review the possible effects when using modern hydroxyethylstarch solutions 6 % versus albumin 5% during living donor renal transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin group | Active comparator | Other: Albumin resuscitation, Drug: Albumin 5%Albumin resuscitation Albumin 5% |
| Hydroxyethylstarch group | Experimental | Other: Hydroxyethylstarch resuscitation, Drug: Hydroxyethylstarch 6%Hydroxyethylstarch resuscitation Hydroxyethylstarch 6% |
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 renal transplantation
Key exclusion criteria (1 listed)
- severe cardiac or hepatic dysfunction, re-transplantation, 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 |
|---|---|---|
| Albumin resuscitationAlbumin 5% is used as the intra-operative colloid | Other | Albumin group |
| Hydroxyethylstarch resuscitationHydroxyethyl starch 6% is used as the intra-operative colloid | Other | Hydroxyethylstarch group |
| Albumin 5%Also: AlbuminInfusion of Albumin 5% intra-operatively | Drug | Albumin group |
| Hydroxyethylstarch 6%Also: TetraspanInfusion of Hydroxyethylstarch 6% intra-operatively | Drug | Hydroxyethylstarch group |
Primary outcome
Occurrence of complications
Time frame: 7 days
Increased creatinine and/or need for dialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ahmed Kareem study director
Kasr Al-Ainy Hospiral, 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 Albumin resuscitation, Hydroxyethylstarch resuscitation and Albumin 5% in people with Anesthesia Morbidity, run by Cairo 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 28 Jan 2020. 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?
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?
Occurrence of complications (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 28 Jan 2020.