Trial Outcomes & Findings for Surgical Stress Markers for Postoperative Complications: a Prospective Study (NCT NCT02356484)

Results Overview

Delta albumin (g/l) before (day -1) and immediately (day 1) after surgery as a predictor of postoperative complications (until 30 days post surgery)

Recruitment status

COMPLETED

Target enrollment

150 participants

Primary outcome timeframe

Albumin preoperatively (day -1) and postoperatively (day 1) after surgery

Results posted on

2020-08-07

150 inclusions planned 155 patients screened 17 refusals study stopped after 138 inclusions due to long recruitment time

From the 155 patients initially eligible for the study, 17 refused to participate, thus 138 patients were included in the study

Participant milestones
Measure	Major Abdominal Surgery Cohort One-arm study including all patients undergoing "major abdominal surgery according to the provided definition.
Overall Study STARTED	138
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Surgical Stress Markers for Postoperative Complications: a Prospective Study

Baseline characteristics by cohort
Measure	Major Abdominal Surgery Cohort n=138 Participants In this surgical cohort, 4 inflammatory markers were measured: albumin, procalcitonin, CRP and lactate levels
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants
Region of Enrollment Switzerland	138 participants n=5 Participants

Timeframe: Albumin preoperatively (day -1) and postoperatively (day 1) after surgery

Delta albumin (g/l) before (day -1) and immediately (day 1) after surgery as a predictor of postoperative complications (until 30 days post surgery)

Outcome measures
Measure	Major Abdominal Surgery Cohort n=138 Participants Albumin was measured preoperatively and in postoperative day 1 for all 138 study participants
Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications	11.3 g/L Standard Deviation 5.6

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events
Measure	Major Abdominal Surgery Cohort n=138 participants at risk Patients undergoing major abdominal surgery according to the provided definition
Cardiac disorders Cardiorespiratory arrest	0.72% 1/138 • Number of events 1

Adverse event data not reported

Lausanne University Hospital

Phone: 0041213142424