NCT05637606 - HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery | Biotech Hunter

Enrollment

636

Participants

Timeline

Start Date

March 6, 2023

Primary Completion Date

May 21, 2025

Study Completion Date

May 21, 2025

Conditions

Blood PressureComplication,PostoperativeIntraoperative Hypotension

Interventions

DRUG

Ephedrine

In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg). The maximal dose for the ephedrine allowed is 25 mg (10 boluses of 2.5 mg), after this threshold a continuous infusion of norepinephrine will be started

DRUG

Norepinephrine

In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg) or Etilefrine (1 mg). The continuous infusion of norepinephrine, as decided by the attending anesthetist, may be started at any point of the intraoperative period. The starting dose of norepinephrine is the lowest needed to reach the predefined MAP target.

DRUG

Etilefrine Hydrochloride bolus

The maximal dose for the etilefrine allowed is 10 mg (10 boluses of 1 mg), after this threshold a continuous infusion of norepinephrine will be started

DIAGNOSTIC_TEST

Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)

PPV, SVV and mini\_FC will guide fluid bolus administration during an episode of intraoperative hypotension, following two predefined algorithms for laparotomic/non laparotomic surgery

Trial Locations (18)

20089

Humanitas Research Hospital, Rozzano

50134

Careggi University Hospital, Florence

Unknown

Ospedali Riuniti Foggia- Università di Foggia, Foggia

Department of Anesthesia and Intensive Care, University Hospital of Modena, Modena

Policlinico A. Gemelli, Rome

Fondazione Istituto San Raffaele G. Giglio, Cefalù

Unit of Anesthesiology and Intensive Care B, Department of Surgery, Dentistry, Gynecology and Pediatrics, AOUI-University Hospital Integrated Trust of Verona, Verona

Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo, Alessandria

ASST Grande Ospedale Metropolitano Niguarda, Milan

Istituto Nazionale dei Tumori, Milan

Ospedale Antonio Cardarelli, Napoli

Azienda sanitaria Friuli Occidentale (AsFO], Pordenone

Ospedale Santo Stefano, Prato

Ospedale S. Anna di Castelnovo ne' Monti, Reggio Emilia

Sant'Eugenio ASL Roma 2:, Roma

Azienda Ospedaliero Universitaria di Sassari, Sassari

Ospedale Molinette, Torino

Ospedale Santa Chiara di Trento, Trento