Portal Blood PressureEarly Phase 1NCT02993640
Optimization of Hepatic Hemodynamics During Liver Surgery
A Early Phase 1 study testing vasopressin + nitro in people with Portal Blood Pressure and Liver Surgery, run by Sahlgrenska University Hospital.
Trial summary
The purpose of this study is to determine if vasopressin and nitroglycerin in combination will affect hepatic hemodynamics, in the setting of liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Blood Pressure, Liver Surgery, Hepatic Hemodynamics
- What is being tested?
- vasopressin + nitro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 20 Mar 2017
- Phase
- Early Phase 1
- 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
- Patients within ASA-class I-II scheduled for open liver resection
Who cannot join
- ASA-class III and IV, more than 2 medications for hypertension, BMI > 35, technical difficulties with insertion av catheters, extensive surgery.
About this study
Official title: Effects of Vasopressin and Nitroglycerine in Combination on Splanchnic Blood Flow, and on Hepatic and Portal Venous Pressures in Liver Resection
The purpose of this study is to determine if vasopressin and nitroglycerin in combination will affect hepatic hemodynamics, in the setting of liver surgery.
Read the detailed description
The patients in this study (undergoing elective liver resection) will be anesthetized according to routine practice in our hospital. A radial arterial catheter and a central venous catheter will be inserted, as well as a femoral arterial catheter for Picco monitoring. After the dissection phase, catheters will be inserted in the portal and hepatic veins by the surgeon. Base line data (HR, CVP, MAP, CO from thermodilution, portal and hepatic venous pressure, blood gases from radial artery, vena cava superior, hepatic vein and portal vein) will be obtained twice, with 10 minutes of steady state in between. An infusion of vasopressin 4,8 U/h will then be started and continued for 20 minutes. Data will be collected again, and an infusion of nitroglycerine (to a target of MAP 60 mmHg) will be added. After 5 minutes of steady MAP 55-65, the last set of data is collected. 12 Patients will be recruited, and the total data collection is estimated to be completed and assessed after six to nine months.
- Conditions
- Portal Blood Pressure, Liver Surgery, Hepatic Hemodynamics
- Being tested
- vasopressin + nitro
- Keywords
- vasopressin, nitroglycerine, portal pressure, portal flow
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasopressin + nitroDrug
vasopressin infusion 4,8 U/h for 20 minutes, thereafter nitroglycerine infusion to a MAP of 60 for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| vasopressin + nitro | Experimental | vasopressin + nitroglycerin in simultaneous infusion Receives: Drug: vasopressin + nitro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal and hepatic venous flow after vasopressin and nitroglycerine infusion
Measured: six - nine months
Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion
Measured: six - nine months
Secondary outcomes (1)
lactate in the splanchnic circulation
Measured: six-nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startSep 2016
- Primary completion20 Mar 2017
- Study completion20 Mar 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 Portal Blood PressureStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellinor Wisén, Sahlgrenska University Hospital
- Investigators
- Sven-Erik Ricksten, Professor, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993640
- Sponsor's protocol ID
- EPN879-13
- Status last verified
- Nov 2018
- First submitted
- 12 Dec 2016
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plans of sharing IPD
Publications
Wisen E, Svennerholm K, Bown LS, Houltz E, Rizell M, Lundin S, Ricksten SE. Vasopressin and nitroglycerin decrease portal and hepatic venous pressure and hepato-splanchnic blood flow. Acta Anaesthesiol Scand. 2018 Aug;62(7):953-961. doi: 10.1111/aas.13117. Epub 2018 Mar 26.
PubMed 29578250
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vasopressin and Nitroglycerine in Combination on Splanchnic Blood Flow, and on Hepatic and Portal Venous Pressures in Liver Resection
- ClinicalTrials.gov ID
- NCT02993640
- Acronym / sponsor ID
- EPN879-13
- Conditions
- Portal Blood Pressure, Liver Surgery, Hepatic Hemodynamics
- Keywords
- vasopressin, nitroglycerine, portal pressure, portal flow
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 15 Dec 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.
The purpose of this study is to determine if vasopressin and nitroglycerin in combination will affect hepatic hemodynamics, in the setting of liver surgery.
Detailed description
The patients in this study (undergoing elective liver resection) will be anesthetized according to routine practice in our hospital. A radial arterial catheter and a central venous catheter will be inserted, as well as a femoral arterial catheter for Picco monitoring. After the dissection phase, catheters will be inserted in the portal and hepatic veins by the surgeon. Base line data (HR, CVP, MAP, CO from thermodilution, portal and hepatic venous pressure, blood gases from radial artery, vena cava superior, hepatic vein and portal vein) will be obtained twice, with 10 minutes of steady state in between. An infusion of vasopressin 4,8 U/h will then be started and continued for 20 minutes. Data will be collected again, and an infusion of nitroglycerine (to a target of MAP 60 mmHg) will be added. After 5 minutes of steady MAP 55-65, the last set of data is collected. 12 Patients will be recruited, and the total data collection is estimated to be completed and assessed after six to nine months.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vasopressin + nitro | Experimental | Drug: vasopressin + nitrovasopressin + nitroglycerin in simultaneous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients within ASA-class I-II scheduled for open liver resection
Key exclusion criteria (1 listed)
- ASA-class III and IV, more than 2 medications for hypertension, BMI > 35, technical difficulties with insertion av catheters, extensive surgery.
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 |
|---|---|---|
| vasopressin + nitrovasopressin infusion 4,8 U/h for 20 minutes, thereafter nitroglycerine infusion to a MAP of 60 for 5 minutes. | Drug | vasopressin + nitro |
Primary outcome
Portal and hepatic venous flow after vasopressin and nitroglycerine infusion
Time frame: six - nine months
Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion
Time frame: six - nine months
1 secondary outcome
lactate in the splanchnic circulation
Time frame: six-nine months
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 8 Nov 2018.
- Derived from this study: PubMed 29578250Wisen E, Svennerholm K, Bown LS, Houltz E, Rizell M, Lundin S, Ricksten SE. Vasopressin and nitroglycerin decrease portal and hepatic venous pressure and hepato-splanchnic blood flow. Acta Anaesthesiol Scand. 2018 Aug;62(7):953-961. doi: 10.1111/aas.13117. Epub 2018 Mar 26.
- Individual participant dataSharing planned: No. No plans of sharing IPD
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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.
Sven-Erik Ricksten, Professor study director
Sahlgrenska University Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing vasopressin + nitro in people with Portal Blood Pressure and Liver Surgery, run by Sahlgrenska University Hospital.
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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 and hepatic venous flow after vasopressin and nitroglycerine infusion (time frame: six - nine months). The study lists 2 primary outcomes in all. 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 NCT02993640, 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 8 Nov 2018.