An interventional study of Ephedrine and Norepinephrine in Blood Pressure, Complication,Postoperative and Intraoperative Hypotension, sponsored by Humanitas Clinical and Research Center. Completed at 18 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Humanitas Clinical and Research Center · Not applicable, Interventional, and Treatment
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.
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 636 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Humanitas Clinical and Research Center is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
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AND
At increased risk of postoperative complications (at least one of the following):
Exclusion criteria
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.
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)
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.
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)
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
Also known as: Ephedrine bolus
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.
Also known as: norepinephrine infusion
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
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
Also known as: Hemodynamic optimization
Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).
Composite postoperative outcome
Time frame: up to 30 days after operation
Hospital stay (days)
Hospital stay (days)
Time frame: up to 30 days after operation
ICU stay (days)
Intensive Care Unit stay (days)
Time frame: up to 30 days after operation
ICU readmission
Intensive Care Unit readmissions
Time frame: up to 30 days after operation
Sequential Organ Failure Assessment (SOFA) scores on postoperative
Postoperative organ failure - SOFA scores ranges from 0 (\<2% of mortality) to 24 (\>90% of mortality)
Time frame: up to 7 days after operation
Overall intraoperative fluid balance
Intraoperative infusions (crystalloids, colloids, blood products) / Intraoperative loss balance (urine output)
Time frame: day 1 after the operation
Mortality
Mortality
Time frame: up to 30 days after operation
Vasopressors use
Dose and timing of vasoactive drug infusion intraoperatively
Time frame: day 1 after the operation
Need for reoperation
Need of a new surgical treatment
Time frame: day 30 after operation
CARDIOVASCULAR complications
* Acute heart failure * Myocardial injury after non-cardiac surgery * Myocardial infarction * Bradycardia * Symptomatic proximal deep venous thrombosis * Peripheral arterial and venous thrombosis
Time frame: day 7 after operation
NEUROLOGICAL complications
* Stroke * Subarachnoid hemorrhage * Cerebral venous thrombosis * Seizure * Acute delirium
Time frame: day 7 after operation
RESPIRATORY
* Acute respiratory distress * Hypoxemia with or without acute respiratory distress * Need for invasive, non-invasive ventilation or high-flow nasal cannula for acute respiratory distress. * Acute respiratory distress syndrome. * Pulmonary edema * Pulmonary embolism
Time frame: day 7 after operation
RENAL
• Acute Kidney Injury (AKI) and AKI stages defined according to the AKIN classification/staging system of acute kidney injury
Time frame: day 7 after operation
SEPSIS and Septic shock
Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis required a quick Sequential Organ Failure Assessment (qSOFA) Score ≥ 2 points due to infection, septic shock defined as indicated by the Surviving Sepsis Campaign Guidelines
Time frame: day 7 after operation
Plan to share: Undecided
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Humanitas Clinical and Research Center