General AnesthesiaPhase 4NCT03965117
Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy.
A Phase 4 study testing Norepinephrine in people with General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Maintaining adequate blood pressure is important for survival of organs. Recent studies have demonstrated that higher blood pressures were necessary for prevention of acute kidney injury and myocardial injury after non-cardiac surgery. Hypotension after induction and maintenance of anesthesia is common. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 28 May 2019to 14 Oct 2022
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 years ≤ 80 years (female or male)
- ASA I - II - III
- Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
- Patient is scheduled for pancreatic surgery.
Who cannot join
- Allergy to the medication.
- Renal insufficiency (SCr > 2 mg/dL).
- Severe heart failure (EF < 25%).
- Hemodynamic instable patients.
- Atrial fibrillation.
- Sepsis.
Show all 11Show fewer
- BMI > 40.
- Severe coagulopathy (INR > 2).
- Thrombocytopenia (< 80 x 103 /mcL).
- End stage liver disease.
- Pregnancy and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Maintaining adequate blood pressure is important for survival of organs. Recent studies have demonstrated that higher blood pressures were necessary for prevention of acute kidney injury and myocardial injury after non-cardiac surgery. Hypotension after induction and maintenance of anesthesia is common. For maintaining adequate blood pressure in a euvolemic patient, vasopressor therapy is required. Norepinephrine (NOR) is commonly used to treat anesthesia-related hypotension.
The hepatic circulation has a large number of alpha and beta adrenergic receptors and is very sensitive for adrenergic stimulation such as norepinephrine infusion. Animal studies (Hiltebrand et al.) suggest that NOR has only minimal effect on hepatic blood flow however the effect of NOR on hepatic blood flow in clinical surgical patients remains unclear.
Read more
The aim of the study is to evaluate the effect of NOR on hepatic blood flow during.
goal directed haemodynamic therapy.
Read the detailed description
All patients receive standardized anesthesia care for pancreas surgery according to the existing departmental protocol for these interventions.
All patients receive individualized goal-directed haemodynamic therapy based on the transpulmonary thermodilution technique.
At designated times, hemodynamic variables will be recorded. These include:
- Heart rate (bpm)
- Central venous pressure (mmHg)
- Mean arterial pressure (mmHg)
- Cardiac index (L/min/m2)
- Pulse pressure variation (PPV)
Blood flow and pressure measurements performed by the surgeon :
- Hepatic flow : hepatic artery (HAF) and portal vein (PVF)
- Pressure measurements in portal vein (PPorta) and caval vein (PCava)
Both flow and pressure will be simultaneously recorded. To minimize the effect of ventilation on pressure, these measurements will be obtained during apnea.
Between each flow measurement there will be a minimum of 5 minutes.
NOR will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. After baseline MAP (which is > 60 mmHg), NOR is targeted according baseline MAP. At T2, MAP is between 10 - 20 % above baseline (T1), at T3 MAP is between 20 - 30 % above baseline (T1).
- Conditions
- General Anesthesia
- Being tested
- Norepinephrine
- Keywords
- hepatic blood flow, Norepinephrine, hepatic vascular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
norepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. After baseline MAP (which is > 60 mmHg), norepinephrine is targeted according baseline MAP. At T2, MAP is between 10 - 20 % above baseline (T1), at T3 MAP is between 20 - 30 % above baseline (T1).
| Study group | Role | What they receive |
|---|---|---|
| norepinephrine | Experimental | norepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in hepatic blood flow during goal-directed hemodynamic therapy with norepinphrine
flow measurements with echo probe
Measured: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in hepatic blood pressures during goal-directed hemodynamic therapy with norepinphrine
pressure measurements with needle
Measured: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
Secondary outcomes (5)
change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with norepinphrine
change in systemic vascular resistance (SVR)
Measured: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in portal venous resistance (PVR) during goal-directed hemodynamic therapy with norepinphrine
change in portal venous resistance (PVR)
Measured: From start anesthesia until end of anesthesia up to a maximum of 11 hours
change in cardiac index during goal-directed hemodynamic therapy with norepinphrine
change in cardiac index
Measured: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
amount of blood loss
amount of blood loss at end of surgery
Measured: from start of surgery until end of surgery, up to a maximum of 10 hours
amount of fluids given during surgery with goal-directed hemodynamic therapy with norepinphrine
total amount of cristalloids and colloids given during surgery
Measured: from start of surgery until end of surgery up to a maximum of 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start28 May 2019
- Primary completion22 Oct 2020
- Study completion14 Oct 2022
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 General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jurgen Van Limmen, MD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965117
- Sponsor's protocol ID
- 2019/0395
- Status last verified
- Dec 2022
- First submitted
- 20 May 2019
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Limmen J, Iturriagagoitia X, Verougstraete M, Wyffels P, Berrevoet F, Abreu de Carvalho LF, De Hert S, De Baerdemaeker L. Effect of norepinephrine infusion on hepatic blood flow and its interaction with somatostatin: an observational cohort study. BMC Anesthesiol. 2022 Jul 2;22(1):202. doi: 10.1186/s12871-022-01741-2.
PubMed 35780092
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy.
- ClinicalTrials.gov ID
- NCT03965117
- Acronym / sponsor ID
- 2019/0395
- Conditions
- General Anesthesia
- Keywords
- hepatic blood flow, Norepinephrine, hepatic vascular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 28 May 2019 (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.
Maintaining adequate blood pressure is important for survival of organs. Recent studies have demonstrated that higher blood pressures were necessary for prevention of acute kidney injury and myocardial injury after non-cardiac surgery. Hypotension after induction and maintenance of anesthesia is common. For maintaining adequate blood pressure in a euvolemic patient, vasopressor therapy is required. Norepinephrine (NOR) is commonly used to treat anesthesia-related hypotension.
The hepatic circulation has a large number of alpha and beta adrenergic receptors and is very sensitive for adrenergic stimulation such as norepinephrine infusion. Animal studies (Hiltebrand et al.) suggest that NOR has only minimal effect on hepatic blood flow however the effect of NOR on hepatic blood flow in clinical surgical patients remains unclear.
The aim of the study is to evaluate the effect of NOR on hepatic blood flow during.
goal directed haemodynamic therapy.
Detailed description
All patients receive standardized anesthesia care for pancreas surgery according to the existing departmental protocol for these interventions.
All patients receive individualized goal-directed haemodynamic therapy based on the transpulmonary thermodilution technique.
At designated times, hemodynamic variables will be recorded. These include:
- Heart rate (bpm)
- Central venous pressure (mmHg)
- Mean arterial pressure (mmHg)
- Cardiac index (L/min/m2)
- Pulse pressure variation (PPV)
Blood flow and pressure measurements performed by the surgeon :
- Hepatic flow : hepatic artery (HAF) and portal vein (PVF)
- Pressure measurements in portal vein (PPorta) and caval vein (PCava)
Both flow and pressure will be simultaneously recorded. To minimize the effect of ventilation on pressure, these measurements will be obtained during apnea.
Between each flow measurement there will be a minimum of 5 minutes.
NOR will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. After baseline MAP (which is > 60 mmHg), NOR is targeted according baseline MAP. At T2, MAP is between 10 - 20 % above baseline (T1), at T3 MAP is between 20 - 30 % above baseline (T1).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| norepinephrine | Experimental | Drug: Norepinephrinenorepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult ≥ 18 years ≤ 80 years (female or male)
- ASA I - II - III
- Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
- Patient is scheduled for pancreatic surgery.
Key exclusion criteria (11 listed)
- Allergy to the medication.
- Renal insufficiency (SCr > 2 mg/dL).
- Severe heart failure (EF < 25%).
- Hemodynamic instable patients.
- Atrial fibrillation.
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 |
|---|---|---|
| Norepinephrinenorepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. After baseline MAP (which is > 60 mmHg), norepinephrine is targeted according baseline MAP. At T2, MAP is between 10 - 20 % above baseline (T1), at T3 MAP is between 20 - 30 % above baseline (T1). | Drug | norepinephrine |
Primary outcome
change in hepatic blood flow during goal-directed hemodynamic therapy with norepinphrine
Time frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
flow measurements with echo probe
change in hepatic blood pressures during goal-directed hemodynamic therapy with norepinphrine
Time frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
pressure measurements with needle
5 secondary outcomes
change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with norepinphrine
Time frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in portal venous resistance (PVR) during goal-directed hemodynamic therapy with norepinphrine
Time frame: From start anesthesia until end of anesthesia up to a maximum of 11 hours
change in cardiac index during goal-directed hemodynamic therapy with norepinphrine
Time frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
amount of blood loss
Time frame: from start of surgery until end of surgery, up to a maximum of 10 hours
amount of fluids given during surgery with goal-directed hemodynamic therapy with norepinphrine
Time frame: from start of surgery until end of surgery up to a maximum of 10 hours
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 Dec 2022.
- Derived from this study: PubMed 35780092van Limmen J, Iturriagagoitia X, Verougstraete M, Wyffels P, Berrevoet F, Abreu de Carvalho LF, De Hert S, De Baerdemaeker L. Effect of norepinephrine infusion on hepatic blood flow and its interaction with somatostatin: an observational cohort study. BMC Anesthesiol. 2022 Jul 2;22(1):202. doi: 10.1186/s12871-022-01741-2.
- Individual participant dataSharing planned: No
Related trials for General Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
Jurgen Van Limmen, MD principal investigator
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine in people with General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
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 11 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 Dec 2022. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
change in hepatic blood flow during goal-directed hemodynamic therapy with norepinphrine (time frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours). 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 NCT03965117, 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 9 Dec 2022.