Status:
COMPLETED
Study of Early Enteral Dextrose in Sepsis
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective single-center randomized double-blinded placebo-controlled clinical trial testing the effects of early enteral dextrose as a therapeutic agent in critically ill patients wi...
Detailed Description
The central objective of this research project is to determine how early caloric support impacts inflammatory and metabolic outcomes in the acute phase of sepsis. Preliminary data from our mouse model...
Eligibility Criteria
Inclusion
- New presentation of sepsis characterized by a confirmed or suspected infection, with an acute increase from baseline in a modified Sepsis-Related Organ Failure Assessment (SOFA) score of greater than or equal to 2 points. If baseline values are unknown, baseline SOFA score of 0 will be assumed.
- Available enteral access defined by: (1) an existing nasogastric or orogastric tube, (2) plans to place a nasogastric or orogastric tube, or (3) an existing percutaneous endoscopic gastrostomy (PEG) tube.
- Less than 48 hours since meeting criteria for sepsis.
- Expected to stay at least 24 hours in the ICU.
Exclusion
- Pre-existing continuous enteral tube feed use prior to study entry.
- Diabetic ketoacidosis or diabetic hyperosmolar hyperglycemic syndrome.
- Previously enrolled in this study within the same hospital admission.
- ICU physician request to exclude patient based on clinical assessment.
Key Trial Info
Start Date :
June 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03454087
Start Date
June 4 2018
End Date
April 1 2020
Last Update
April 7 2020
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15237