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

NCT03965117 | Completed Phase 4 DMC

• 1 other identifier: 2019/0395
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

hepatic blood flow; Norepinephrine; hepatic vascular pressure

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with norepinphrine

  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

  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

  From start anesthesia until end of anesthesia, up to a maximum of 11 hours

• amount of blood loss

  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

  from start of surgery until end of surgery up to a maximum of 10 hours

Study Arms (1)

norepinephrine

EXPERIMENTAL

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

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

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).

norepinephrine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35780092 DERIVED

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jurgen Van Limmen, MD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 28, 2019
• Study Start: May 28, 2019
• Primary Completion: October 22, 2020
• Study Completion: October 14, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)