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

Not Applicable

Recruiting

• Conditions: Complication,Postoperative; Intraoperative Hypotension; Blood Pressure
• Interventions: Drug: Ephedrine; Drug: Norepinephrine; Drug: Etilefrine Hydrochloride bolus; Diagnostic Test: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)

• Registration Number: NCT05637606
• Lead Sponsor: Humanitas Clinical and Research Center

Brief Summary

This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.

Detailed Description

Intraoperative hypotension has been associated with major postoperative complications after non-cardiac surgery. However, is is still unclear the optimal intraoperative mean arterial pressure (MAP) target in the subgroup of those patient with an history of hypertension at home, and at risk of developing postoperative complications.

The objective of this study is to assess the effects of an intraoperative blood pressure management strategy aiming at keeping the MAP ≥ 80mmHg), as compared to the conventional practice (to maintain intraoperative MAP ≥ 65mmHg), on a composite outcome considering the death rate and the incidence of major events in patient scheduled for elective laparotomic/laparoscopic surgery.

The primary outcome is a composite of 30-days from operation mortality rate and at least one major organ dysfunction including the renal, respiratory, cardiovascular and neurologic systems or new onset of sepsis and septic shock occurring by day 7 after surgery.

Study Timeline

• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-11-24
• Study First Posted: 2022-12-05
• Study Start: 2023-03-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 636

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAP 80	Etilefrine Hydrochloride bolus	Intervention group: intraoperative mean blood pressure target \> 80 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 80 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.
MAP 80	Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)	Intervention group: intraoperative mean blood pressure target \> 80 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 80 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.
MAP 65	Ephedrine	Control group: intraoperative mean blood pressure target \> 65 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 65 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.
MAP 65	Etilefrine Hydrochloride bolus	Control group: intraoperative mean blood pressure target \> 65 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 65 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.
MAP 65	Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)	Control group: intraoperative mean blood pressure target \> 65 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 65 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.
MAP 65	Norepinephrine	Control group: intraoperative mean blood pressure target \> 65 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 65 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.
MAP 80	Ephedrine	Intervention group: intraoperative mean blood pressure target \> 80 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 80 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.
MAP 80	Norepinephrine	Intervention group: intraoperative mean blood pressure target \> 80 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 80 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.

Primary Outcome Measures

Name	Time	Method
Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).	up to 30 days after operation	Composite postoperative outcome

Secondary Outcome Measures

Name	Time	Method
Hospital stay (days)	up to 30 days after operation	Hospital stay (days)
ICU stay (days)	up to 30 days after operation	Intensive Care Unit stay (days)
ICU readmission	up to 30 days after operation	Intensive Care Unit readmissions
Sequential Organ Failure Assessment (SOFA) scores on postoperative	up to 7 days after operation	Postoperative organ failure - SOFA scores ranges from 0 (\<2% of mortality) to 24 (\>90% of mortality)
Overall intraoperative fluid balance	day 1 after the operation	Intraoperative infusions (crystalloids, colloids, blood products) / Intraoperative loss balance (urine output)
Mortality	up to 30 days after operation	Mortality
Vasopressors use	day 1 after the operation	Dose and timing of vasoactive drug infusion intraoperatively
Need for reoperation	day 30 after operation	Need of a new surgical treatment

Trial Locations

Locations (18)

Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Istituto Europeo di Oncologia (IEO); 🇮🇹 Milano, Italy

Department of Anesthesia, Critical Care and Pain Medicine, SS. Annunziata Hospital; 🇮🇹 Chieti, Abruzzo, Italy

Department of Anesthesia and Intensive Care, University Hospital of Modena; 🇮🇹 Modena, Emilia Romagna, Italy

Policlinico A. Gemelli; 🇮🇹 Roma, Lazio, Italy

Humanitas Research Hospital; 🇮🇹 Rozzano, Milano, Italy

Ospedali Riuniti Foggia- Università di Foggia; 🇮🇹 Foggia, Puglia, Italy

Fondazione Istituto San Raffaele G. Giglio; 🇮🇹 Cefalù, Sicilia, Italy

Division of Anesthesia and Intensive Care, University of Messina, Policlinico "G. Martino"; 🇮🇹 Messina, Sicilia, Italy

Department of Surgical Oncological and Oral Science, University of Palermo; 🇮🇹 Palermo, Sicilia, Italy

Careggi University Hospital; 🇮🇹 Firenze, Toscana, Italy

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

Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milan, Italy

Ospedale Antonio Cardarelli; 🇮🇹 Napoli, Italy

Azienda sanitaria Friuli Occidentale (AsFO]; 🇮🇹 Pordenone, Italy

Ospedale S. Anna di Castelnovo ne' Monti; 🇮🇹 Reggio Emilia, Italy

Ospedale Molinette; 🇮🇹 Torino, Italy