Dopexamine and Norepinephrine Compared With Epinephrine Alone in Septic Shock
|ClinicalTrials.gov Identifier: NCT00134212|
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : January 2, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: Dopexamine and norepinephrine Drug: Epinephrine||Phase 2|
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 0.2 µg/kg/min with 0.2 µg/kg/min increments every 3 min for epinephrine and norepinephrine, and from 0.5 µg/kg/min with 0.5 µg/kg/min increments every 3 min for dopexamine.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2002|
|Estimated Study Completion Date :||June 2004|
- Gastric mucosal blood flow assessed using a laser-Doppler flowmeter
- Systemic and pulmonary hemodynamics: systolic, diastolic and mean arterial, right atrial, systolic, diastolic and mean pulmonary arterial, and pulmonary capillary wedge pressures
- heart rate, stroke volume, cardiac output
- systemic and pulmonary vascular resistances
- arterial and venous blood gases and arterial lactate
- alanine and aspartate amino transferases
- α-glutathione S-transferase
- nitric oxide and reactive oxygen species productions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134212
|Rennes University Hospital|
|Rennes, France, 35033|
|Study Director:||Yannick Mallédant, MD||Rennes University Hospital|
|Study Chair:||Eric Bellissant, MD, PhD||Rennes University Hospital|
|Principal Investigator:||Philippe Seguin, MD||Rennes University Hospital|