Trial Outcomes & Findings for Indication for Intraoperative Volume Therapy (NCT NCT01454258)
NCT ID: NCT01454258
Last Updated: 2017-09-14
Results Overview
Recruitment status
COMPLETED
Target enrollment
10100 participants
Primary outcome timeframe
24h
Results posted on
2017-09-14
Participant Flow
Participant milestones
| Measure |
Cohort
Surgical patients from 10 hospitals over a period of 13 months
|
|---|---|
|
Overall Study
STARTED
|
10100
|
|
Overall Study
COMPLETED
|
9103
|
|
Overall Study
NOT COMPLETED
|
997
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Indication for Intraoperative Volume Therapy
Baseline characteristics by cohort
| Measure |
Cohort
n=10100 Participants
Surgical patients from 10 hospitals over a period of 13 months
|
|---|---|
|
Age, Customized
|
NA years
n=99 Participants
|
|
Sex/Gender, Customized
|
NA participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24hPopulation: Surgical patients from 10 hospitals over a period of 13 months
Outcome measures
| Measure |
Crystalloids
n=9103 Participants
crystalloids
|
Hydroxyethyl Starch
n=9103 Participants
HES
|
Other Colloids
n=9103 Participants
gelatine, albumin,
|
|---|---|---|---|
|
Number of Different Substitution Solutions Administered
|
7827 participants
|
1055 participants
|
221 participants
|
Adverse Events
Cohort
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
Prof Dr Dr Kai Zacharowski, FRCA
University Hospital Frankfurt
Phone: 004969630186668
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place