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NCT04136080 Clinical Trial

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

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04136080
Other study ID # 2019-05-025
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date November 30, 2021

Study information
Verified date October 2019
Source Fujian Provincial Hospital
Contact shang xiuling, Phd
Phone 13763895158
Email zksxling@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 752
Est. completion date November 30, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• vasopressors
control the mean arterial pressure with vasopressors

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fujian Provincial Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary the 28-day all-cause mortality and Changes of sublingual microcirculation the 28-day all-cause mortality and Changes of sublingual microcirculation 28 day
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