Trial Outcomes & Findings for Direct Peritoneal Resuscitation Effects in the Damage Control Patient (NCT NCT01771055)
NCT ID: NCT01771055
Last Updated: 2021-06-16
Results Overview
Evaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
1 Month
Results posted on
2021-06-16
Participant Flow
Participant milestones
| Measure |
Control
Standard of care without peritoneal resuscitation
|
Direct Peritoneal Resuscitation
Subjects received standard operation plus direct peritoneal resuscitation after surgery
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Direct Peritoneal Resuscitation Effects in the Damage Control Patient
Baseline characteristics by cohort
| Measure |
Galactose
n=3 Participants
Galactose
Galactose: Galactose dripped into the abdomen after surgery
|
Standard Resuscitation
n=4 Participants
Standard surgical methods of controlling bleeding
Standard surgical methods
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 MonthEvaluate the Number of participants with Morbidity receiving Direct Peritoneal Resuscitation versus those receiving standard care.
Outcome measures
| Measure |
Galactose
n=3 Participants
Galactose
Galactose: Galactose dripped into the abdomen after surgery
|
Standard Resuscitation
n=4 Participants
Standard surgical methods of controlling bleeding
Standard surgical methods without galactose
|
|---|---|---|
|
Number of Participants With Morbidity
|
0 number of participants
|
0 number of participants
|
Adverse Events
Galactose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Resuscitation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place