HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Ephedrine
- Conditions
- Blood Pressure
- Sponsor
- Humanitas Clinical and Research Center
- Enrollment
- 636
- Locations
- 18
- Primary Endpoint
- Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Antonio Messina
Principal Investigator
Humanitas Clinical and Research Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MAP 80
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.
Intervention: Ephedrine
MAP 80
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.
Intervention: Norepinephrine
MAP 80
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.
Intervention: Etilefrine Hydrochloride bolus
MAP 80
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.
Intervention: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)
MAP 65
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.
Intervention: Ephedrine
MAP 65
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.
Intervention: Norepinephrine
MAP 65
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.
Intervention: Etilefrine Hydrochloride bolus
MAP 65
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.
Intervention: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)
Outcomes
Primary Outcomes
Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).
Time Frame: up to 30 days after operation
Composite postoperative outcome
Secondary Outcomes
- Sequential Organ Failure Assessment (SOFA) scores on postoperative(up to 7 days after operation)
- Hospital stay (days)(up to 30 days after operation)
- ICU stay (days)(up to 30 days after operation)
- ICU readmission(up to 30 days after operation)
- Overall intraoperative fluid balance(day 1 after the operation)
- Mortality(up to 30 days after operation)
- Vasopressors use(day 1 after the operation)
- Need for reoperation(day 30 after operation)