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Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome

NCT00159510 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-10-06

No results posted yet for this study

Summary

Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in sepsis the excessive production of NO results in myocardial depression, vasoplegia, and cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed study from our group showed advantageous cardiovascular effects of continuously infused methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another investigation, we have found that the combination of inhaled NO and continuously infused MB attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both cardiovascular and pulmonary functions as well as clinical outcome in patients with septic shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic shock and ALI, will be randomized to groups receiving

1. Conventional treatment (control group)(n =10);
2. MB infusion in addition to conventional treatment (n=10);
3. Inhaled NO in addition to conventional treatment (n=10);
4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment (n=10).

Conditions

Interventions

DRUG

Methylene blue

Injection bolus of 2 mg/kg PBW and infusion of 0.2 mg/kg/hr

DRUG

Nitric oxide

An inhalation of NO via ETT at 10 ppm, partially weaned by 72 hrs of therapy

DRUG

Methylene blue & nitric oxide

See the dosage in the previous arms

Sponsors & Collaborators

  • Helse Nord

    collaborator INDUSTRY

  • Northern State Medical University

    lead OTHER

Principal Investigators

  • Mikhail Y Kirov, MD, PhD · Northern State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00159510 on ClinicalTrials.gov