Liver TransplantationNCT04376281
The Effect of Norepinephrine on Cardiac Output in Patients Undergoing Liver Transplant .
A study testing Noradrenaline in people with Liver Transplantation, run by Cairo University at 1 site in Egypt.
Trial summary
Early administration of NE in liver transplant recipient might enhance cardiac output through an increase in cardiac preload . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Noradrenaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2019to 1 Oct 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Adults (age > 18 years) patients undergoing living donor liver transplant (LDLT) will be considered for inclusion in the study..
Who cannot join
- Patients less than 18 years.
- Patients undergoing liver transplantation for acute liver failure .
- All Chronic Hypertensive patients on medication , whether controlled on not controlled
- Those with high risk of post transplant renal dysfunction (serum creatinine >1.5 mg/dL at time of transplant)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Norepinephrine on Blood Volume Cardiac , Output and Systemic Filling Pressure in Patients Undergoing Liver Transplant .
Early administration of NE in liver transplant recipient might enhance cardiac output through an increase in cardiac preload .
Read the detailed description
The derangement of circulatory blood volume in patients with liver cirrhosis makes intraoperative fluid management during liver transplant is challenging . Cirrhotic patients not only have large blood volume but abnormal blood volume distribution, with a substantial fraction of this volume in the splanchnic circulation (. These hemodynamic changes render volume loading in these patients has little impact on CO because a large proportion of infused fluid is shifted to the splanchnic system . In addition, patients with liver cirrhosis is similar to septic patients who have increased total vascular compliance which may cause pooling of blood in venous pool. Several studies in patients with sepsis found that use of low dose vasopressor may convert unstressed blood volume (i.e the amount of blood not causing pressure on the vessels) to stressed volume (i.e additional blood causing a distending pressure on the vascular walls and reflects the effective circulating volume) . However, no previous studies tested the effect of using norepinephrine (NE) on venous return and cardiac preload in patients undergoing liver transplant. An obvious advantage of this possibility is that NE will be used instead of true fluid replacement which may minimize fluid replacement during operation.
Recently, a method was described to estimate the changes in intravascular volume and vascular capacitance by calculating mean systemic filling pressure (MSFP) . MSFP is the driving pressure in venous return, and it allows calculation of the arterial and venous components of systemic vascular resistance .
- Conditions
- Liver Transplantation
- Being tested
- Noradrenaline
- Keywords
- Liver transplantaion , fluid management , noradrenaline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoradrenalineDrug
Noradrenaline infusion for patients undergoing liver transplantaion from living donor .
| Study group | Role | What they receive |
|---|---|---|
| Noradrenaline group | Experimental | Not described Receives: Drug: Noradrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Noradrenaline on change of cardiac output .
The effect of Noradrenaline on change of cardiac output .
Measured: along the procedure ; from skin incision to the end of surgery
Secondary outcomes (3)
The effect of NE on mean systemic filling pressure .
The effect of NE on mean systemic filling pressure .
Measured: along the procedure ; from skin incision to the end of surgery
The effect of NE on venous return .
The effect of NE on venous return .
Measured: along the procedure ; from skin incision to the end of surgery
The effect of NE on central venous pressure .
The effect of NE on central venous pressure .
Measured: along the procedure ; from skin incision to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start15 Dec 2019
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Hussein Sayed, Cairo University
- Investigators
- Ahmed M Mukhtar, MD, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376281
- Sponsor's protocol ID
- MD.241-2019
- Status last verified
- Nov 2021
- First submitted
- 15 Apr 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rudnick MR, Marchi LD, Plotkin JS. Hemodynamic monitoring during liver transplantation: A state of the art review. World J Hepatol. 2015 Jun 8;7(10):1302-11. doi: 10.4254/wjh.v7.i10.1302.
PubMed 26052376Moller S, Bendtsen F, Henriksen JH. Effect of volume expansion on systemic hemodynamics and central and arterial blood volume in cirrhosis. Gastroenterology. 1995 Dec;109(6):1917-25. doi: 10.1016/0016-5085(95)90759-9.
PubMed 7498657Mukhtar A, Dabbous H. Modulation of splanchnic circulation: Role in perioperative management of liver transplant patients. World J Gastroenterol. 2016 Jan 28;22(4):1582-92. doi: 10.3748/wjg.v22.i4.1582.
PubMed 26819524Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.
PubMed 19237896
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Norepinephrine on Blood Volume Cardiac , Output and Systemic Filling Pressure in Patients Undergoing Liver Transplant .
- ClinicalTrials.gov ID
- NCT04376281
- Acronym / sponsor ID
- MD.241-2019
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantaion , fluid management , noradrenaline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 6 May 2020 (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.
Early administration of NE in liver transplant recipient might enhance cardiac output through an increase in cardiac preload .
Detailed description
The derangement of circulatory blood volume in patients with liver cirrhosis makes intraoperative fluid management during liver transplant is challenging . Cirrhotic patients not only have large blood volume but abnormal blood volume distribution, with a substantial fraction of this volume in the splanchnic circulation (. These hemodynamic changes render volume loading in these patients has little impact on CO because a large proportion of infused fluid is shifted to the splanchnic system . In addition, patients with liver cirrhosis is similar to septic patients who have increased total vascular compliance which may cause pooling of blood in venous pool. Several studies in patients with sepsis found that use of low dose vasopressor may convert unstressed blood volume (i.e the amount of blood not causing pressure on the vessels) to stressed volume (i.e additional blood causing a distending pressure on the vascular walls and reflects the effective circulating volume) . However, no previous studies tested the effect of using norepinephrine (NE) on venous return and cardiac preload in patients undergoing liver transplant. An obvious advantage of this possibility is that NE will be used instead of true fluid replacement which may minimize fluid replacement during operation.
Recently, a method was described to estimate the changes in intravascular volume and vascular capacitance by calculating mean systemic filling pressure (MSFP) . MSFP is the driving pressure in venous return, and it allows calculation of the arterial and venous components of systemic vascular resistance .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noradrenaline group | Experimental | Drug: Noradrenaline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Adults (age > 18 years) patients undergoing living donor liver transplant (LDLT) will be considered for inclusion in the study..
Key exclusion criteria (4 listed)
- Patients less than 18 years.
- Patients undergoing liver transplantation for acute liver failure .
- All Chronic Hypertensive patients on medication , whether controlled on not controlled
- Those with high risk of post transplant renal dysfunction (serum creatinine >1.5 mg/dL at time of transplant)
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 |
|---|---|---|
| NoradrenalineNoradrenaline infusion for patients undergoing liver transplantaion from living donor . | Drug | Noradrenaline group |
Primary outcome
The effect of Noradrenaline on change of cardiac output .
Time frame: along the procedure ; from skin incision to the end of surgery
The effect of Noradrenaline on change of cardiac output .
3 secondary outcomes
The effect of NE on mean systemic filling pressure .
Time frame: along the procedure ; from skin incision to the end of surgery
The effect of NE on venous return .
Time frame: along the procedure ; from skin incision to the end of surgery
The effect of NE on central venous pressure .
Time frame: along the procedure ; from skin incision to the end of surgery
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 9 Nov 2021.
- Background: PubMed 26052376Rudnick MR, Marchi LD, Plotkin JS. Hemodynamic monitoring during liver transplantation: A state of the art review. World J Hepatol. 2015 Jun 8;7(10):1302-11. doi: 10.4254/wjh.v7.i10.1302.
- Background: PubMed 7498657Moller S, Bendtsen F, Henriksen JH. Effect of volume expansion on systemic hemodynamics and central and arterial blood volume in cirrhosis. Gastroenterology. 1995 Dec;109(6):1917-25. doi: 10.1016/0016-5085(95)90759-9.
- Background: PubMed 26819524Mukhtar A, Dabbous H. Modulation of splanchnic circulation: Role in perioperative management of liver transplant patients. World J Gastroenterol. 2016 Jan 28;22(4):1582-92. doi: 10.3748/wjg.v22.i4.1582.
- Background: PubMed 19237896Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.
- 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 M Mukhtar, MD study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noradrenaline in people with Liver Transplantation, 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 4 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 9 Nov 2021. 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?
The effect of Noradrenaline on change of cardiac output . (time frame: along the procedure ; from skin incision to the end of surgery). 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 NCT04376281, which also lists 4 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 9 Nov 2021.