Phenylephrine in Septic Shock
This study has been completed.
Sponsor:
University of Roma La Sapienza
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00639015
First received: March 12, 2008
Last updated: August 15, 2008
Last verified: March 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The present study was conducted as a prospective, randomized, controlled study to compare:
- the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock
- to test the hypothesis that norepinephrine may likewise better preserve hepatosplanchnic perfusion versus phenylephrine in patients suffering from septic shock
| Condition | Intervention | Phase |
|---|---|---|
|
Septic Shock |
Drug: Phenylephrine Drug: Norepinephrine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial |
Resource links provided by NLM:
Drug Information available for:
Norepinephrine bitartrate
Norepinephrine
Phenylephrine
Phenylephrine hydrochloride
Oxymetazoline
Oxymetazoline hydrochloride
U.S. FDA Resources
Further study details as provided by University of Roma La Sapienza:
Primary Outcome Measures:
- Systemic and regional hemodynamics [ Time Frame: during the first 12 hours from the onset of septic shock ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Organ functions,adverse effects [ Time Frame: during the first 12 hours from the onset of septic shock ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | November 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Phenylephrine
|
Drug: Phenylephrine
Titrated phenylephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
|
|
Active Comparator: 2
Norepinephrine
|
Drug: Norepinephrine
Titrated norepinephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
|
Detailed Description:
Thirty two septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. Patients will be randomly allocated to be treated with either a) titrated phenylephrine, b) titrated norepinephrine (control; each n = 16), to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, will be obtained at baseline and after 12 hours.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of Septic shock
- Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)
Exclusion Criteria:
- Pregnancy
- Age < 18 years
- Present cardiac dysfunction
- Present or suspected acute mesenteric ischemia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639015
Locations
| Italy | |
| Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155 | |
| Rome, Italy, 00161 | |
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
| Study Director: | Andrea Morelli, M.D. | Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" |
More Information
No publications provided by University of Roma La Sapienza
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Andrea Morelli, University of Rome "La Sapienza" |
| ClinicalTrials.gov Identifier: | NCT00639015 History of Changes |
| Other Study ID Numbers: | 1282 |
| Study First Received: | March 12, 2008 |
| Last Updated: | August 15, 2008 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Roma La Sapienza:
|
Sepsis Septic Shock phenylephrine norepinephrine catecholamine |
Additional relevant MeSH terms:
|
Shock Shock, Septic Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Norepinephrine Phenylephrine Oxymetazoline Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic alpha-1 Receptor Agonists Cardiotonic Agents Mydriatics Nasal Decongestants Respiratory System Agents Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013