The Effect of Early Use of Methylene Blue on Hemodynamics in Septic Shock

Septic Shock Clinical Trial

Official title:

The Effect of Early Use of Methylene Blue on Hemodynamics in Septic Shock

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04970602
• Other study ID #: 20210621
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: June 2021
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will include patients requiring high dose of norepinephrine (NA) to maintain blood pressure after fluid resuscitation. The patients will be randomized into two groups, the study protocol is early combined application of methylene blue. The primary outcome is Sequential Organ Failure Assessment (SOFA) score 72 hours after admission. Second outcome includes duration of shock, length of intensive care unit (ICU) hospitalization and so on. To explore the underlying mechanism, the changes of sublingual microcirculation before and after vasopressor combination will be collected, also is the global longitudinal strain of left ventricle.

Description:

Background: Decreased vascular tone is one of the main mechanisms leading to septic shock. The guidelines recommend NA as the first-line vasopressor. The benefits of early combination with other vasopressors are not yet known.

Methods:

1. Patients: Septic shock patients in need of high dose of NA (≥0.5ug/kg.min maintaining more than 2 hours) to maintain blood pressure after fluid resuscitation.

2. Intervention: The patients will be randomized into two groups. The study group will receive 2mg/kg methylene blue infusion with 15 minutes, 2 hours laters followed by 0.5mg/kg/h for 4 hours. The control group received conventional treatments, the attending physicians decide the protocol of vasopressors. The data including patients' characters, duration of shock and hospitalization, duration of mechanical ventilation, cumulative dose of vasopressors will be collected. Before and 6h after meeting the inclusion standard, sublingual microcirculation and automated function imaging of myocardium will be performed.

3. Outcome: The primary outcome is SOFA score 72 hours after admission. Second outcome includes duration of shock, length of ICU hospitalization and so on. the changes of sublingual microcirculation will be collected, also is the global longitudinal strain of left ventricle.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: January 1, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Septic shock, receive 0.5 ug/kg/min NA to maintain blood pressure for more than 2 hours after fluid resuscitation.

Exclusion Criteria:

• Pregnant women

• Without internal jugular vein or subclavian vein catheterization

• Child-Pugh grade C with liver cirrhosis

• Severe chronic obstructive pulmonary disease (severe acidosis caused by type II respiratory failure, PaCO2 =60mmHg and PH<7.2 )

• End-stage of malignant tumors

• Glucose-6-phosphate dehydrogenase (G6PD enzyme) deficiency

• Positive end-respiratory pressure (PEEP) >10mmHg, the oxygenation index <150mmHg under mechanical ventilation

• Definitive pulmonary hypertension or chronic pulmonary heart disease.

• Oral use of 5-hydroxytryptamine in recent 3 months

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Methylene Blue
Once the patient meets inclusion criterial, the interventional group will receive 2mg/kg methylene blue infusion within 20min, followed by 0.5mg/kg/h for 4 hours.

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SOFA score	72 hours after inclusion	72 hours
Secondary	duration of shock	the duration between diagnosis and relief of septic shock, the latter is defined by stable blood pressure without any vasopressor for 2 hours	2 hours