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Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy.

Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03965117
Enrollment
49
Registered
2019-05-28
Start date
2019-05-28
Completion date
2022-10-14
Last updated
2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

hepatic blood flow, Norepinephrine, hepatic vascular pressure

Brief 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. 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).

Interventions

DRUGNorepinephrine

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).

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Allergy to the medication. * Renal insufficiency (SCr \> 2 mg/dL). * Severe heart failure (EF \< 25%). * Hemodynamic instable patients. * Atrial fibrillation. * Sepsis. * BMI \> 40. * Severe coagulopathy (INR \> 2). * Thrombocytopenia (\< 80 x 103 /mcL). * End stage liver disease. * Pregnancy and breastfeeding women

Design outcomes

Primary

MeasureTime frameDescription
change in hepatic blood flow during goal-directed hemodynamic therapy with norepinphrineFrom start anesthesia until end of anesthesia, up to a maximum of 11 hoursflow measurements with echo probe
change in hepatic blood pressures during goal-directed hemodynamic therapy with norepinphrineFrom start anesthesia until end of anesthesia, up to a maximum of 11 hourspressure measurements with needle

Secondary

MeasureTime frameDescription
change in cardiac index during goal-directed hemodynamic therapy with norepinphrineFrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in cardiac index
change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with norepinphrineFrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in systemic vascular resistance (SVR)
amount of fluids given during surgery with goal-directed hemodynamic therapy with norepinphrinefrom start of surgery until end of surgery up to a maximum of 10 hourstotal amount of cristalloids and colloids given during surgery
amount of blood lossfrom start of surgery until end of surgery, up to a maximum of 10 hoursamount of blood loss at end of surgery
change in portal venous resistance (PVR) during goal-directed hemodynamic therapy with norepinphrineFrom start anesthesia until end of anesthesia up to a maximum of 11 hourschange in portal venous resistance (PVR)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026