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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: General Anesthesia

Treatments: Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03965117

2019/0395

Details and patient eligibility

About

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.

Full 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).

Enrollment: 49 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

norepinephrine

Experimental group

Description:

norepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect.

Treatment:

Drug: Norepinephrine