The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock

NCT ID: NCT04136080

Last Updated: 2019-10-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-11-30

Brief Summary

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Background: The mean arterial pressure( MAP) is a key pressure index to improve tissue perfusion. At present, there are no surprising results of large-scale clinical studies on sublingual microcirculation. The changes of sublingual microcirculation were more severe in septic shock non-survivors than survivors. Purpose: This study is mean to increase the MAP in septic shock patients whether with chronic hypertension or not, so as to observe the change of the microcirculation and prognosis. Method: This is a single-center, randomized, prospective cohort study. Eligible patients will be allocated into chronic hypertension or denying chronic hypertension group. These patients will be treat with vasopressors to maintain MAP at 90±5 mmHg and 70±5 mmHg. Outcome: The 28-day all-cause mortality, the 90-day all-cause mortality, the 28-day without organ dysfunction days, the Changes of sublingual microcirculation, SOFA, APACHE-Ⅱ score Will be recorded.

Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chronic hypertension group

septic patients with chronic hypertension

Group Type OTHER

vasopressors

Intervention Type OTHER

control the mean arterial pressure with vasopressors

denying chronic hypertension group

septic patients without chronic hypertension

Group Type OTHER

vasopressors

Intervention Type OTHER

control the mean arterial pressure with vasopressors

Interventions

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vasopressors

control the mean arterial pressure with vasopressors

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Adult patients (≥18 years) admitted to The Critical Medicine Departments Three of Fujian Provincial Hospital will be considered eligible,who are presence of infection or suspected infection,requiring mechanical ventilation. At the same time, without the vasopressors the MAP would be less than 65mmHg, and the blood lactic acid level is higher than 2mmol/l.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Provincial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiuling Shang

Senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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shang xiuling, Phd

Role: CONTACT

13763895158

Other Identifiers

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2019-05-025

Identifier Type: -

Identifier Source: org_study_id

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