Trial Outcomes & Findings for Hyperglycemia in Surgical Infections (NCT NCT00353275)

NCT ID: NCT00353275

Last Updated: 2018-11-21

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Duration of hospital stay, an average of 2 weeks

Results posted on

2018-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Strict Glycemic Control Blood glucose target range is 80-110 mg/dL.	Conventional Glycemic Control Blood glucose target range is 110-140 mg/dL.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hyperglycemia in Surgical Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Strict Glycemic Control n=2 Participants Blood glucose target range is 80-110 mg/dL.	Conventional Glycemic Control n=3 Participants Blood glucose target range is 110-140 mg/dL.	Total n=5 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 11 • n=5 Participants	59 years STANDARD_DEVIATION 5 • n=7 Participants	59 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Weight	169 pounds n=5 Participants	240 pounds n=7 Participants	212 pounds n=5 Participants
Height	66 inches n=5 Participants	65 inches n=7 Participants	66 inches n=5 Participants

PRIMARY outcome

Timeframe: Duration of hospital stay, an average of 2 weeks

Population: The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Duration of hospital stay

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of hospital stay

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of hospital stay

Outcome measures

Outcome data not reported

Adverse Events

Strict Glycemic Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Glycemic Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lillian S. Kao

UT Health Science Center at Houston

Phone: 713-566-5095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place