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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965117
• Other study ID #: 2019/0395
• Status: Completed
• Phase: Phase 4
• Start date: May 28, 2019
• Est. completion date: October 14, 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 14, 2022
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Drug:
• Norepinephrine
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).

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in hepatic blood flow during goal-directed hemodynamic therapy with norepinphrine	flow measurements with echo probe	From start anesthesia until end of anesthesia, up to a maximum of 11 hours
Primary	change in hepatic blood pressures during goal-directed hemodynamic therapy with norepinphrine	pressure measurements with needle	From start anesthesia until end of anesthesia, up to a maximum of 11 hours
Secondary	change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with norepinphrine	change in systemic vascular resistance (SVR)	From start anesthesia until end of anesthesia, up to a maximum of 11 hours
Secondary	change in portal venous resistance (PVR) during goal-directed hemodynamic therapy with norepinphrine	change in portal venous resistance (PVR)	From start anesthesia until end of anesthesia up to a maximum of 11 hours
Secondary	change in cardiac index during goal-directed hemodynamic therapy with norepinphrine	change in cardiac index	From start anesthesia until end of anesthesia, up to a maximum of 11 hours
Secondary	amount of blood loss	amount of blood loss at end of surgery	from start of surgery until end of surgery, up to a maximum of 10 hours
Secondary	amount of fluids given during surgery with goal-directed hemodynamic therapy with norepinphrine	total amount of cristalloids and colloids given during surgery	from start of surgery until end of surgery up to a maximum of 10 hours