N/A
Completed N=1,102
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Source: ClinicalTrials.gov NCT01195883 ↗Enrolled (actual)
1,102
Serious AEs
18.4%
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants With Postoperative Morbidity (Major Complications) — 103; 91 Participants — p=0.51
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.
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 |
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. Informational only — not medical advice.