N/A
N=1,102
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Postoperative Complications
Bottom Line
View on ClinicalTrials.gov: NCT01195883 ↗Enrolled (actual)
1,102
Serious AEs
18.4%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With Postoperative Morbidity (Major Complications) — 103; 91 Participants — p=0.51
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Crystalloid (Drug); Colloid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Morbidity (Major Complications) |
103; 91 | 0.51 |
| SECONDARY Number of Participants With Postoperative Morbidity (Minor Complications) |
234; 214 | 0.42 |
| SECONDARY Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death |
143; 125 | 0.26 |
| SECONDARY Number of Participants With Postoperative Acute Kidney Injury |
21; 16 | 0.40 |
Summary
A trial in which patients having open abdominal surgery are randomized to receive either crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators test the primary hypothesis that goal-directed colloid administration during elective abdominal surgery decreases a composite of postoperative complications within 30 days of surgery.
Eligibility Criteria
Inclusion Criteria
- ASA Physical Status 1-3
- Body Mass Index 3.
Data sourced from ClinicalTrials.gov (NCT01195883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.