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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004139-66-BE

Enrollment

Registered

2019-03-25

Start date

2019-04-11

Completion date

Unknown

Last updated

2022-03-02

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

Conditions

hepatic blood flow hepatic vascular pressures

Interventions

Trade Name: Noradrenaline (Norepinephrine) Aguettant 1 mg/ml concentraat voor oplossing voor infusie Pharmaceutical Form: Solution for infusion INN or Proposed INN: NORADRENALINE TARTRATE CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: • Allergy to the medication. • Renal insufficiency (SCr > 2 mg/dL). • Severe heart failure (EF 40. • Severe coagulopathy (INR > 2). • Thrombocytopenia (< 80 x 103 /mcL). • End stage liver disease. • Pregnancy and breastfeeding women

Design outcomes

Primary

Measure	Time frame
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 • T2 – after pancreatectomy, after reaching target MAP 10 – 20% above baseline (T1). • T3 – before surgical reconstruction and after reaching target MAP 20 – 30% above baseline (T1).	—

Measure

Time frame

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 • T2 – after pancreatectomy, after reaching target MAP 10 – 20% above baseline (T1). • T3 – before surgical reconstruction and after reaching target MAP 20 – 30% above baseline (T1).

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Secondary

Measure	Time frame
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. • T1 – after pancreatectomy at baseline MAP • T2 – after pancreatectomy, after reaching target MAP 10 – 20% above baseline (T1). • T3 – before surgical reconstruction and after reaching target MAP 20 – 30% above baseline (T1). • T4 – before closure of the abdominal cavity.	—

Measure

Time frame

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. • T1 – after pancreatectomy at baseline MAP • T2 – after pancreatectomy, after reaching target MAP 10 – 20% above baseline (T1). • T3 – before surgical reconstruction and after reaching target MAP 20 – 30% above baseline (T1). • T4 – before closure of the abdominal cavity.

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Countries

Belgium

Contacts

Public ContactHiruz CTU

Ghent University Hospital

Hiruz.ctu@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026