Hemodynamics, Liver, TerlipressinPhase 2NCT02718599
Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery
A Phase 2 study testing terlipressin and normal saline in people with Hemodynamics, Liver, Terlipressin, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamics, Liver, Terlipressin
- What is being tested?
- terlipressin and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Any gender.
- ASA (American Society of Anesthesiologists) Classification( Class I-II)
- Patients undergoing major elective hepatobiliary surgery.
Who cannot join
- Preoperative renal failure (GFR < 50 ml/min).
- Severe liver dysfunction (Child- turcotte -Pugh grade C).
- Hyponatremia (<132 mmol/l).
- Severe aortic regurgitation, severe mitral regurgitation, heart failure.
- Symptomatic coronary heart disease.
- Bradycardic arrhythmia (heart rate < 60/min).
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- Peripheral artery occlusive disease (clinical stadium II-IV).
- Uncontrolled arterial hypertension (Blood pressure >160/100 mmHg despite intensive treatment).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery
- Conditions
- Hemodynamics, Liver, Terlipressin
- Being tested
- terlipressin, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressinDrug
Also called glypressin
Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.
normal salineDrug
Also called 0.9 Nacl
Patients receive 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin | Active comparator | Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours. Receives: Drug: terlipressin |
| CONTROL | Placebo comparator | Patients receive the same volume of 0.9% saline in place of terlipressin for the same duration(50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours). Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
portal pressure changes
portal pressure changes in mmHg
Measured: intraoperative period
Secondary outcomes (3)
Effect on systemic vascular resistance
•Effect on systemic vascular resistance in dyne.s/cm5
Measured: intraoperative period
Renal impairment
Number of patients with renal impairment [defined as at least a doubling of serum creatinine or oliguria (<500 mL/24 hours)].
Measured: for 3 days in the postoperative period
Blood units transfused
Number of packed RBCs (red blood cells) units transfused
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamics, Liver, TerlipressinStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Mohammed Mahdy Sayed, Assiut University
- Investigators
- Mostafa Samy, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718599
- Sponsor's protocol ID
- ABC-123-DE
- Status last verified
- Mar 2016
- First submitted
- 19 Mar 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.
PubMed 31200638
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery
- ClinicalTrials.gov ID
- NCT02718599
- Acronym / sponsor ID
- ABC-123-DE
- Conditions
- Hemodynamics, Liver, Terlipressin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipressin | Active comparator | Drug: terlipressinTerlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours. |
| CONTROL | Placebo comparator | Drug: normal salinePatients receive the same volume of 0.9% saline in place of terlipressin for the same duration(50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years.
- Any gender.
- ASA (American Society of Anesthesiologists) Classification( Class I-II)
- Patients undergoing major elective hepatobiliary surgery.
Key exclusion criteria (9 listed)
- Preoperative renal failure (GFR < 50 ml/min).
- Severe liver dysfunction (Child- turcotte -Pugh grade C).
- Hyponatremia (<132 mmol/l).
- Severe aortic regurgitation, severe mitral regurgitation, heart failure.
- Symptomatic coronary heart disease.
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 |
|---|---|---|
| terlipressinAlso: glypressinTerlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours. | Drug | Terlipressin |
| normal salineAlso: 0.9 NaclPatients receive 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours. | Drug | CONTROL |
Primary outcome
portal pressure changes
Time frame: intraoperative period
portal pressure changes in mmHg
3 secondary outcomes
Effect on systemic vascular resistance
Time frame: intraoperative period
Renal impairment
Time frame: for 3 days in the postoperative period
Blood units transfused
Time frame: intraoperative period
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 19 Dec 2017.
- Derived from this study: PubMed 31200638Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.
- Individual participant dataSharing planned: Undecided
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.
Mostafa Samy study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing terlipressin and normal saline in people with Hemodynamics, Liver, Terlipressin, 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 4 inclusion and 9 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 19 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. Some participants in this study may receive a placebo. 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?
portal pressure changes (time frame: intraoperative period). 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 NCT02718599, 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 19 Dec 2017.