Effect of Different Strategies for Titrating a High MAP on Microcirculation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-09-30

Brief Summary

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Assess the effect of fluids and norepinephrine for mean arterial pressure titration to patients' usual level on the microcirculation of initial resuscitated hypertensive septic shock patients.

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Detailed Description

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Microcirculatory dysfunction plays an important role in the development of organ failure in patients with septic shock. Numerous studies focus on the effect of mean arterial pressure (MAP) titration on microcirculation, however, by what strategy is better for microcirculation in septic shock patients with previous hypertension is still a matter of debate. The goal of this study was to assess the effect of different strategies for MAP titration to individualized level on microcirculation in hypertensive septic shock patients.

Conditions

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Septic Shock Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Resp-FL

Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one. The target MAP was maintain MAP within 10% of the reference value.

Group Type EXPERIMENTAL

Crystalloid

Intervention Type DRUG

Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one.

Resp-NE

In Resp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Norepinephrine infusion to titrate MAP to usual level

Nonresp-NE

In Nonresp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Norepinephrine infusion to titrate MAP to usual level

Interventions

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Norepinephrine

Norepinephrine infusion to titrate MAP to usual level

Intervention Type DRUG

Crystalloid

Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one.

Intervention Type DRUG

Other Intervention Names

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NE group Fluid group

Eligibility Criteria

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Inclusion Criteria

1. Hypertensive patients with septic shock for less than 24 hours. Septic shock was defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference.
2. Initial fluid resuscitation was performed to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous hemoglobin saturation for more than 70%.
3. Patients were still requiring NE to maintain the MAP of 65 mm Hg.

Exclusion Criteria

1. had severe untreated or uncontrolled hypertension (systolic blood pressure more than 180 mm Hg or/and diastolic blood pressure more than 110 mm Hg);
2. were younger than 18 years old or pregnant;
3. were unable to acquire the usual level or resting level of blood pressure;
4. refused to participate the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No