Effect of norepinephrine infusion on hepatic blood flow during goal-directed hemodynamic therapy.

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]; hepatic blood flow hepatic vascular pressures

• Registration Number: EUCTR2018-004139-66-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

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.
•Scheduled for pancreatic surgery.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of norepinephrine infusion (NOR) on hepatic blood flow and hepatic vascular pressures during goal-directed hemodynamic therapy.;Secondary Objective: To evaluate the effects of NOR on systemic vascular resistance (SVR), portal venous resistance (PVR), cardiac index (CI), blood loss and total fluid administration.;Primary end point(s): Evaluation of the effect of NOR on hepatic blood flow and pressures during goal-directed hemodynamic therapy.;Timepoint(s) of evaluation of this end point: •T1 – after pancreatectomy at baseline MAP<br>•T2 – after pancreatectomy, after reaching target MAP 10 – 20% above baseline (T1).<br>•T3 – before surgical reconstruction and after reaching target MAP 20 – 30% above baseline (T1).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of the effect of NOR on systemic vascular resistance (SVR), portal venous resistance (PVR), CI, blood loss en fluid administration.;Timepoint(s) of evaluation of this end point: •T0 – after incision and opening of the abdominal cavity.<br>•T1 – after pancreatectomy at baseline MAP<br>•T2 – after pancreatectomy, after reaching target MAP 10 – 20% above baseline (T1).<br>•T3 – before surgical reconstruction and after reaching target MAP 20 – 30% above baseline (T1).<br>•T4 – before closure of the abdominal cavity.