Effect of Different Strategies for Titrating a High MAP on Microcirculation

Study Overview
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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.

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.

Official Title
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The Effect of Fluids and Norepinephrine for Mean Arterial Pressure Titration to Patients' Usual Levels on the Microcirculation of Initial Resuscitated Hypertensive Septic Shock Patients.

Conditions
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Septic Shock, Hypertension

Intervention / Treatment
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* Drug: Norepinephrine
* Drug: Crystalloid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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%. Patients were still requiring NE to maintain the MAP of 65 mm Hg. Exclusion Criteria: had severe untreated or uncontrolled hypertension (systolic blood pressure more than 180 mm Hg or/and diastolic blood pressure more than 110 mm Hg); were younger than 18 years old or pregnant; were unable to acquire the usual level or resting level of blood pressure; refused to participate the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resp-FL<br>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. | Drug: Crystalloid<br>* 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.<br>* Other names: Fluid group;|
| Experimental: Resp-NE<br>In Resp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value. | Drug: Norepinephrine<br>* Norepinephrine infusion to titrate MAP to usual level<br>* Other names: NE group;|
| Experimental: Nonresp-NE<br>In Nonresp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value. | Drug: Norepinephrine<br>* Norepinephrine infusion to titrate MAP to usual level<br>* Other names: NE group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfused vessel density | Perfused vessel density of small vessels | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock; microcirculation; norepinephrine