Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159510
Status:
TERMINATED
Last Update Posted:
2015-10-06
First Post:
2005-09-08
Brief Title:
Studies of Acute Lung Injury ALI and Acute Respiratory Distress Syndrome
Sponsor:
Northern State Medical University
Organization:
Northern State Medical University
Study Overview
Official Title:
A Controlled Prospective Randomized Open-Label Study of Methylene Blue and Inhaled Nitric Oxide in Patients With Septic Shock and Acute Lung Injury
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to recruit the patients due to the short supply and changed local hospital protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MB-NO
Brief 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 MBNO 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 groupn 10
2 MB infusion in addition to conventional treatment n10
3 Inhaled NO in addition to conventional treatment n10
4 MB infusion combined with inhaled NO MBNO in addition to conventional treatment n10
1 Conventional treatment control groupn 10
2 MB infusion in addition to conventional treatment n10
3 Inhaled NO in addition to conventional treatment n10
4 MB infusion combined with inhaled NO MBNO in addition to conventional treatment n10
Detailed Description:
The therapy with either MBNO or NO or MB alone will be prolonged for up to 24 h or until resolution of septic shock whichever occurs first MB will be injected as a bolus of 2 mgkg subsequently followed by dose-titrated infusion The latter beginning with 025 mgkgh continuing within the range of from 005 to 05 mgkgh The goal is to maintain mean arterial pressure within the range of 70-90 mm Hg with the purpose of reducing any concurrent vasopressor therapy The NO therapy will be started from 10 ppm and aimed at maintaining the mean pulmonary artery pressure at the lowest possible levels by inhaling NO in concentrations from 1 to 20 ppm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Helse Nord Norway project | OTHER | None | None |
| number 4001721132 | OTHER | HelseNord | None |