Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134212
Status:
COMPLETED
Last Update Posted:
2006-01-02
First Post:
2005-08-22
Brief Title:
Dopexamine and Norepinephrine Compared With Epinephrine Alone in Septic Shock
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Prospective Randomized Study on Two Parallel Groups Comparing Dopexamine and Norepinephrine in Combination to Epinephrine Alone on Systemic and Pulmonary Hemodynamics Gastric Mucosal Perfusion and Oxidative Stress in Septic Shock
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In septic shock when volume resuscitation fails to restore mean arterial pressure catecholamines such as dopamine dobutamine epinephrine or norepinephrine are used either alone or in combination Although they allow hemodynamic success to be obtained they can leave some regional blood flows impaired especially the hepatosplanchnic perfusion which contributes to multiple organ failure
Dopexamine is a structural and synthetic analog of dopamine that exerts systemic and gut vasodilation and stimulates cardiac contraction In experimental models dopexamine has been shown to exert anti-inflammatory properties and to protect the hepatic ultra structure The combination of dopexamine and norepinephrine could therefore constitute an interesting alternative in treating septic shock patients This study will test the efficacy on gastric mucosal blood flow hepatic damage and oxidative stress and safety of the combination of dopexamine and norepinephrine compared to those of epinephrine alone in the treatment of patients with septic shock
Dopexamine is a structural and synthetic analog of dopamine that exerts systemic and gut vasodilation and stimulates cardiac contraction In experimental models dopexamine has been shown to exert anti-inflammatory properties and to protect the hepatic ultra structure The combination of dopexamine and norepinephrine could therefore constitute an interesting alternative in treating septic shock patients This study will test the efficacy on gastric mucosal blood flow hepatic damage and oxidative stress and safety of the combination of dopexamine and norepinephrine compared to those of epinephrine alone in the treatment of patients with septic shock
Detailed Description:
Objective To compare the combination of dopexamine and norepinephrine with epinephrine alone on gastric mucosal blood flow GMBF hepatic damage and oxidative stress in septic shock
Setting Surgical intensive care unit in a university hospital
Design Prospective randomized controlled study on 2 parallel groups
Patients Adults fulfilling usual criteria for septic shock
Interventions Systemic hemodynamics GMBF laser-Doppler plasma α-glutathione S-transferase aspartate aminotransferase alanine aminotransferase and malondialdehyde were assessed just before catecholamine infusion T0 as soon as mean arterial pressure MAP reached 70-80 mmHg T1 and 2 T2 and 6 T3 hours after T1 Drugs were titrated from 02 µgkgmin with 02 µgkgmin increments every 3 min for epinephrine and norepinephrine and from 05 µgkgmin with 05 µgkgmin increments every 3 min for dopexamine
Setting Surgical intensive care unit in a university hospital
Design Prospective randomized controlled study on 2 parallel groups
Patients Adults fulfilling usual criteria for septic shock
Interventions Systemic hemodynamics GMBF laser-Doppler plasma α-glutathione S-transferase aspartate aminotransferase alanine aminotransferase and malondialdehyde were assessed just before catecholamine infusion T0 as soon as mean arterial pressure MAP reached 70-80 mmHg T1 and 2 T2 and 6 T3 hours after T1 Drugs were titrated from 02 µgkgmin with 02 µgkgmin increments every 3 min for epinephrine and norepinephrine and from 05 µgkgmin with 05 µgkgmin increments every 3 min for dopexamine
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 |
|---|---|---|---|
| CIC0203008 | None | None | None |
| LOC-H01-08 | None | None | None |