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

NCT04136080 | Unknown

• 1 other identifier: 2019-05-025
• Study Type: interventional
• Target: 752
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• the 28-day all-cause mortality and Changes of sublingual microcirculation

  the 28-day all-cause mortality and Changes of sublingual microcirculation

  28 day

Study Arms (2)

chronic hypertension group

OTHER

septic patients with chronic hypertension

Other: vasopressors

denying chronic hypertension group

OTHER

septic patients without chronic hypertension

Other: vasopressors

Interventions

vasopressors OTHER

control the mean arterial pressure with vasopressors

chronic hypertension group; denying chronic hypertension group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

MeSH Terms

Conditions

Shock, Septic

Interventions

Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

shang xiuling, Phd

CONTACT

13763895158; zksxling@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: December 1, 2019
• Primary Completion: January 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 23, 2019

Record last verified: 2019-10