Terlipressin Adverse ReactionPhase 2NCT03395574
Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation
A Phase 2 study testing Terlipressin and Normal saline in people with Terlipressin Adverse Reaction and Liver Transplantation, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
in our study the investigators aim to assess the effect of terlipressin on cerebral oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial doppler. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terlipressin Adverse Reaction, Liver Transplantation
- 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
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2018to 25 Nov 2018
- 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
- ASA II-IV undergoing orthotopic liver transplantation.
- Age above 18 years.
Who cannot join
- Age below 18 years.
- Patients on Terlipressin preoperative.
- Patients known allergic to Terlipressin.
- Portal vein thrombosis.
- Ischemic heart disease.
- Patients with T. bilirubin level above 7 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Terlipressin on Cerebral Oxygen Saturation and Cerebral Blood Flow During Living Donor Liver Transplantation
in our study the investigators aim to assess the effect of terlipressin on cerebral oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial doppler.
Read the detailed description
All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If pulse pressure variations (PPV) is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain PPV ≤15%. Blood transfusion will be given based on a hemoglobin level (< 7 g/dl) in both (control group) and (terlipressin group). Other blood products will be transfused guided by lab result; Fresh frozen plasma will be given when INR > 2 and platelets will be given when platelets <30.000/mm3. The patients will be randomly allocated into 2 groups; Group T (Terlipressin group) and group S (Normal saline 0.9%).
For (terlipressin group) all patients will receive loading dose of terlipressin (1mg diluted with 50 ml of normal saline 0.9% solution over 30 min) and it will be maintained by continuous infusion at rate of 160 μg per hour (8 ml/h).
For (control group) all patient will receive 50 ml of normal saline 0.9% solution over 30 min and will be maintained continuous infusion at rate of 8 ml/h.
Drugs will be prepared by the nurse and the investigator will be blinded to the drug given.
- 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
drug will be given after 30 minutes of induction of anesthesia
Normal salineDrug
drug will be given after 30 minutes as placebo in control group
| Study group | Role | What they receive |
|---|---|---|
| terlipressin group | Experimental | group will receive terlipressin infusion one mg in 50 ml normal saline will be given over 30 minute as loading dose then will be maintained as infusion of 160 μg per hour (8 ml/h). Receives: Drug: Terlipressin |
| saline (control) group | Placebo comparator | group will receive normal saline infusion 50 ml normal saline will be given over 30 minute as loading dose then will be maintained as infusion of (8 ml/h). Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oxygen saturation
regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead
Measured: one hour after infusion of drug
Secondary outcomes (10)
cerebral oxygen saturation
regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
resistive index of middle cerebral artery
assessed by trans cranial Doppler
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
peak velocity, end diastolic velocity of middle cerebral arteries
assessed by trans cranial Doppler
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
End diastolic velocity of middle cerebral arteries
assessed by trans cranial Doppler
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Heart rate
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Systolic blood pressure
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Diastolic blood pressure
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
PH
assessed by arterial blood gases
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
PCo2
assessed by arterial blood gases
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Po2
assessed by arterial blood gases
Measured: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start25 Jan 2018
- Primary completion25 Nov 2018
- Study completion25 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Terlipressin Adverse ReactionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elayashy Mohamed Ahmed Hassan, Kasr El Aini Hospital
- Investigators
- ahmed mohamed mokhtar, M.D, Study director, kasralainy faculty of medicine, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395574
- Sponsor's protocol ID
- N-113-2017
- Status last verified
- Dec 2018
- First submitted
- 25 Dec 2017
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Czosnyka M, Brady K, Reinhard M, Smielewski P, Steiner LA. Monitoring of cerebrovascular autoregulation: facts, myths, and missing links. Neurocrit Care. 2009;10(3):373-86. doi: 10.1007/s12028-008-9175-7. Epub 2009 Jan 6.
PubMed 19127448Joshi B, Brady K, Lee J, Easley B, Panigrahi R, Smielewski P, Czosnyka M, Hogue CW Jr. Impaired autoregulation of cerebral blood flow during rewarming from hypothermic cardiopulmonary bypass and its potential association with stroke. Anesth Analg. 2010 Feb 1;110(2):321-8. doi: 10.1213/ANE.0b013e3181c6fd12. Epub 2009 Dec 11.
PubMed 20008083Dhiman RK, Kurmi R, Thumburu KK, Venkataramarao SH, Agarwal R, Duseja A, Chawla Y. Diagnosis and prognostic significance of minimal hepatic encephalopathy in patients with cirrhosis of liver. Dig Dis Sci. 2010 Aug;55(8):2381-90. doi: 10.1007/s10620-010-1249-7. Epub 2010 May 28.
PubMed 20508990Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21.
PubMed 22104067Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.
PubMed 10840602
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Terlipressin on Cerebral Oxygen Saturation and Cerebral Blood Flow During Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT03395574
- Acronym / sponsor ID
- N-113-2017
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 25 Nov 2018 (actual)
- First posted
- 10 Jan 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.
in our study the investigators aim to assess the effect of terlipressin on cerebral oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial doppler.
Detailed description
All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If pulse pressure variations (PPV) is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain PPV ≤15%. Blood transfusion will be given based on a hemoglobin level (< 7 g/dl) in both (control group) and (terlipressin group). Other blood products will be transfused guided by lab result; Fresh frozen plasma will be given when INR > 2 and platelets will be given when platelets <30.000/mm3. The patients will be randomly allocated into 2 groups; Group T (Terlipressin group) and group S (Normal saline 0.9%).
For (terlipressin group) all patients will receive loading dose of terlipressin (1mg diluted with 50 ml of normal saline 0.9% solution over 30 min) and it will be maintained by continuous infusion at rate of 160 μg per hour (8 ml/h).
For (control group) all patient will receive 50 ml of normal saline 0.9% solution over 30 min and will be maintained continuous infusion at rate of 8 ml/h.
Drugs will be prepared by the nurse and the investigator will be blinded to the drug given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| terlipressin group | Experimental | Drug: Terlipressingroup will receive terlipressin infusion one mg in 50 ml normal saline will be given over 30 minute as loading dose then will be maintained as infusion of 160 μg per hour (8 ml/h). |
| saline (control) group | Placebo comparator | Drug: Normal salinegroup will receive normal saline infusion 50 ml normal saline will be given over 30 minute as loading dose then will be maintained as infusion of (8 ml/h). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA II-IV undergoing orthotopic liver transplantation.
- Age above 18 years.
Key exclusion criteria (6 listed)
- Age below 18 years.
- Patients on Terlipressin preoperative.
- Patients known allergic to Terlipressin.
- Portal vein thrombosis.
- Ischemic 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 |
|---|---|---|
| Terlipressindrug will be given after 30 minutes of induction of anesthesia | Drug | terlipressin group |
| Normal salinedrug will be given after 30 minutes as placebo in control group | Drug | saline (control) group |
Primary outcome
cerebral oxygen saturation
Time frame: one hour after infusion of drug
regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead
10 secondary outcomes
cerebral oxygen saturation
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
resistive index of middle cerebral artery
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
peak velocity, end diastolic velocity of middle cerebral arteries
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
End diastolic velocity of middle cerebral arteries
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Heart rate
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Systolic blood pressure
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Diastolic blood pressure
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
PH
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
PCo2
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
Po2
Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion
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 24 Dec 2018.
- Background: PubMed 19127448Czosnyka M, Brady K, Reinhard M, Smielewski P, Steiner LA. Monitoring of cerebrovascular autoregulation: facts, myths, and missing links. Neurocrit Care. 2009;10(3):373-86. doi: 10.1007/s12028-008-9175-7. Epub 2009 Jan 6.
- Background: PubMed 20008083Joshi B, Brady K, Lee J, Easley B, Panigrahi R, Smielewski P, Czosnyka M, Hogue CW Jr. Impaired autoregulation of cerebral blood flow during rewarming from hypothermic cardiopulmonary bypass and its potential association with stroke. Anesth Analg. 2010 Feb 1;110(2):321-8. doi: 10.1213/ANE.0b013e3181c6fd12. Epub 2009 Dec 11.
- Background: PubMed 20508990Dhiman RK, Kurmi R, Thumburu KK, Venkataramarao SH, Agarwal R, Duseja A, Chawla Y. Diagnosis and prognostic significance of minimal hepatic encephalopathy in patients with cirrhosis of liver. Dig Dis Sci. 2010 Aug;55(8):2381-90. doi: 10.1007/s10620-010-1249-7. Epub 2010 May 28.
- Background: PubMed 22104067Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21.
- Background: PubMed 10840602Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.
- Individual participant dataSharing planned: No
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 mohamed mokhtar, M.D study director
kasralainy faculty of medicine, Cairo 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 Terlipressin Adverse Reaction and Liver Transplantation, run by Kasr El Aini Hospital 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 2 inclusion and 6 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 24 Dec 2018. 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?
cerebral oxygen saturation (time frame: one hour after infusion of drug). 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 NCT03395574, which also lists 5 linked publications.
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 24 Dec 2018.