Liver Transplant; ComplicationsPhase 3LIVER-PAMNCT05068713
High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial.
A Phase 3 study of Liver Transplant; Complications, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
LIVER PAM A randomized, controled, open and unicentric trial comparing high (MAP 85-90 mmHg) and low (65-70 mmHg) target of mean arterial pressure in the first 24 hours after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Aug 2021to 5 Jan 2024
- Phase
- Phase 3
- 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
- Older than 18 y
- Admitted in the ICU for a post operative care after liver transplant
Who cannot join
- Consent refusal
- Liver transplant due to acute liver failure
- Renal transplant ( Previous or concomitant)
- Refusal from the healthcare provider responsible for the patient
- Renal substitution therapy in the prior 15 days
- Pregnancy
Show all 9Show fewer
- Re-Transplant (Liver transplant in the previous 6 month)
- Hepatorenal syndrome current treatment (Use of terlipressin + Albumin)
- Refractory and persistent shock during or after transplant
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation
LIVER PAM
A randomized, controled, open and unicentric trial comparing high (MAP 85-90 mmHg) and low (65-70 mmHg) target of mean arterial pressure in the first 24 hours after liver transplantation.
- Conditions
- Liver Transplant; Complications
- Being tested
- Usual Care + High Target of Mean Arterial Pressure, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care + High Target of Mean Arterial PressureOther
Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.
Usual CareOther
Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.
| Study group | Role | What they receive |
|---|---|---|
| Hihg Target Mean Arterial Pressure | Experimental | Target of mean arterial pressure of 85-90 mmHg in ther first 24h after liver transplant. Receives: Other: Usual Care + High Target of Mean Arterial Pressure |
| Low Target Mean Arterial Pressure | Active comparator | Target of mean arterial pressure of 65-70 mmHg in ther first 24h after liver transplant. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Acute Kidney Disfunction
Incidence of acute kidney Disfunction according to kdigo criteria.
Measured: 7 days
Secondary outcomes (15)
Mortality
percentage of mortality in 28 days
Measured: 28 days
re-transplant
percentage of re-transplant in 28 days
Measured: 28 days
Lenght of Hospitay Stay
LOS in 28 days
Measured: 28 days
Lenght of ICU Stay
ICU LOS in 28 days
Measured: 28 days
Days alive and out of hospital in 28 days
Number of days alive and out of hospital in 28 days
Measured: 28 days
Substitutive Renal Therapy
percentage of TSR in 7 days
Measured: 7 days
Days Alive and free of renal disfunction
Days Alive and free of renal disfunction in 28 days
Measured: 28 days
Acute kidney insufficiency according to Urinary NGAL on d0 and D2
Percentage of renal disfunction according to NGAL criteria on D0 and D2
Measured: 0d and 2d
MAKE28
Major Kidney Events ( Death, persistent acute kidney disfunction or need of RRT in 28 days)
Measured: 28 days
Liver graft primary disfunction ( Initial Poor Function)
percentage of Initial Poor Function in 7 days
Measured: 7 days
Liver graft primary disfunction (primary nonfunction)
percentage of primary nonfunction in 10 days
Measured: 10 days
Surgical site infection
percentage of SSI in 28 days
Measured: 28 days
Need of Transfusion
percentage of Transfusion requirement in 7 days
Measured: 7 days
Postoperative Major bleeding in 7 days
Bleeding that requires 2 units of blood transfusion in a single day or the need of a reoperation due to bleeding in the first 24 hours after surgery.
Measured: 7 days
Incidence of Arrythmia requiring clinical treatment
percentage of Arrhythmia requiring treatment in 7 days
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 posted6 Oct 2021
- Study start24 Aug 2021
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
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 Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolpho Augusto de Moura Pedro, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068713
- Sponsor's protocol ID
- LIVER-PAM
- Acronym
- LIVER-PAM
- Status last verified
- Jan 2024
- First submitted
- 24 Sep 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pedro RAM, Scharranch BC, Araujo LO, Brandao LS, Andrade LDC, Andraus W, D'Albuquerque LAC, Malbouisson LMS. High versus low mean arterial pressure target in liver transplant patients. An open, controlled, single-center, randomized clinical trial - Protocol and methods (LIVER-PAM). Crit Care Sci. 2023 Mar 1;35(1):11-18. doi: 10.5935/2965-2774.20230336-en.
PubMed 37712725
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation
- ClinicalTrials.gov ID
- NCT05068713
- Acronym / sponsor ID
- LIVER-PAM / LIVER-PAM
- Conditions
- Liver Transplant; Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 6 Oct 2021 (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.
LIVER PAM
A randomized, controled, open and unicentric trial comparing high (MAP 85-90 mmHg) and low (65-70 mmHg) target of mean arterial pressure in the first 24 hours after liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hihg Target Mean Arterial Pressure | Experimental | Other: Usual Care + High Target of Mean Arterial PressureTarget of mean arterial pressure of 85-90 mmHg in ther first 24h after liver transplant. |
| Low Target Mean Arterial Pressure | Active comparator | Other: Usual CareTarget of mean arterial pressure of 65-70 mmHg in ther first 24h after liver transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 y
- Admitted in the ICU for a post operative care after liver transplant
Key exclusion criteria (9 listed)
- Consent refusal
- Liver transplant due to acute liver failure
- Renal transplant ( Previous or concomitant)
- Refusal from the healthcare provider responsible for the patient
- Renal substitution therapy in the prior 15 days
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 |
|---|---|---|
| Usual Care + High Target of Mean Arterial PressureTargeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant. | Other | Hihg Target Mean Arterial Pressure |
| Usual CareTargeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant. | Other | Low Target Mean Arterial Pressure |
Primary outcome
incidence of Acute Kidney Disfunction
Time frame: 7 days
Incidence of acute kidney Disfunction according to kdigo criteria.
15 secondary outcomes
Mortality
Time frame: 28 days
re-transplant
Time frame: 28 days
Lenght of Hospitay Stay
Time frame: 28 days
Lenght of ICU Stay
Time frame: 28 days
Days alive and out of hospital in 28 days
Time frame: 28 days
Substitutive Renal Therapy
Time frame: 7 days
Days Alive and free of renal disfunction
Time frame: 28 days
Acute kidney insufficiency according to Urinary NGAL on d0 and D2
Time frame: 0d and 2d
MAKE28
Time frame: 28 days
Liver graft primary disfunction ( Initial Poor Function)
Time frame: 7 days
Liver graft primary disfunction (primary nonfunction)
Time frame: 10 days
Surgical site infection
Time frame: 28 days
Need of Transfusion
Time frame: 7 days
Postoperative Major bleeding in 7 days
Time frame: 7 days
Incidence of Arrythmia requiring clinical treatment
Time frame: 7 days
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 17 Jan 2024.
- Derived from this study: PubMed 37712725Pedro RAM, Scharranch BC, Araujo LO, Brandao LS, Andrade LDC, Andraus W, D'Albuquerque LAC, Malbouisson LMS. High versus low mean arterial pressure target in liver transplant patients. An open, controlled, single-center, randomized clinical trial - Protocol and methods (LIVER-PAM). Crit Care Sci. 2023 Mar 1;35(1):11-18. doi: 10.5935/2965-2774.20230336-en.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Liver Transplant; Complications, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 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 17 Jan 2024. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
incidence of Acute Kidney Disfunction (time frame: 7 days). 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 NCT05068713, 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 17 Jan 2024.