Heart Rate Control With Esmolol in Septic Shock
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01231698 |
Recruitment Status :
Completed
First Posted : November 1, 2010
Last Update Posted : January 24, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Septic Shock | Drug: esmolol Other: control | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: esmolol |
Drug: esmolol
Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm. |
control |
Other: control
standard treatment without strict heart rate control |
- heart rate [ Time Frame: over a period of 96 hrs ]
- systemic hemodynamics [ Time Frame: over a period of 96 hours ]systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.
- ICU Mortality [ Time Frame: 28 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- septic shock criteria
- presence of heart rate > 95 bpm.
Exclusion Criteria:
- Pregnancy
- age < 18

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231698
Italy | |
Department of Anesthesiology and Intensive care of the University of Rome La Sapienza | |
Rome, Italy |
Principal Investigator: | Andrea Morelli, MD | University of Roma La Sapienza |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Andrea Morelli, MD, University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT01231698 History of Changes |
Other Study ID Numbers: |
2048 |
First Posted: | November 1, 2010 Key Record Dates |
Last Update Posted: | January 24, 2013 |
Last Verified: | November 2011 |
septic shock esmolol tachycardia betablockers |
Shock, Septic Shock Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Esmolol |
Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |