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

NCT04970602 | Unknown DMC

• 1 other identifier: 20210621
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Keywords

septic shock; methylene blue; vasopressor; refractory shock

Outcome Measures

Primary Outcomes (1)

• SOFA score

  72 hours after inclusion

  72 hours

Secondary Outcomes (1)

• duration of shock

  2 hours

Study Arms (2)

MB group

EXPERIMENTAL

This group will be given 2mg/kg methylene blue infusion within 20 minutes, 2 hours later followed by 0.5mg/kg/h for 4 hours.

Drug: Methylene Blue

control group

NO INTERVENTION

This group will be given conventional vasopressors, except methylene blue, based on the attending doctor's decision.

Interventions

Methylene Blue DRUG

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.

MB group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Shock, Septic; Shock

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xiangya Hospital, Central South University

  Department of Critical Care Medicine, Xiangya Hospital, Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 21, 2021
• Study Start: June 20, 2021
• Primary Completion: June 30, 2023
• Study Completion: January 1, 2024
• Last Updated: July 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Within 1 year after completion of the study.
• Access Criteria: Just for academic requirement.

Locations

CN (1)