Patients undergoing emergency laparotomy due to either Intestinal obstruction or perforated abdominal viscus. MedDRA version: 21.1 Level: PT Classification code 10053361 Term: Explorative laparotomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.1 Level: PT Classification code 10051379 Term: Systemic inflammatory response syndrome System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 22.0 Level: PT Classification
Conditions
Interventions
Trade Name: Dexa-Ratiopharm
Pharmaceutical Form: Infusion
INN or Proposed INN: DEXAMETHASONE
CAS Number: 312-93-6
Other descriptive name: DEXAMETHASONE PHOSPHATE
Concentration unit: mg/ml milligram(s)
Sponsors
Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Capital Region of Denmark
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology: a. Primary perforated viscus (perforated ulcer, small intestine or colon) b. Primary intestinal obstruction ( small intestine or colon) 2. Provided verbal and written informed consent 3. Must speak and understand the Danish language Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases. 2. Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage 3. Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute surgery is defined as surgery planned within 48 hours. 4. Intestinal Ischemia 5. intraabdominal bleeding 6. Traumas, gynecological, urogenital and other vascular pathology, pregnant participants. 7. Dementia and/or cognitive dysfunction (diagnosed). 8. Participants not oriented in time, place and person 9. Insuline treatment for diabetes mellitus type I and II 10. Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids) 11. Allergies to trial medicine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate changes in plasma C-reactive protein, assessed 6 hours after surgery and T24*, T72* and T120* (*+/- 6 hours) after surgery. ;Secondary Objective: Postoperative inflammatory responses Fluid distribution, both intravascular and extravascular during the early postoperative period Pulmonary function by Peak Expiratory Flow measurements during the early postoperative period Postoperative need for antiemetic and analgesic beyond standard course during the early perioperative period Fatigue + mobilization, assessed by the physical therapists daily via Cumulated ambulation score Postoperative delirium via Confusion Assessment method Postoperative resting pain measured according to Numeric Rating Scale (NRS) 30-day postoperative mortality 30-day postoperative complications Length of ICU ;Primary end point(s): Changes in plasma C-reactive protein, assessed 6 hours after surgery and T24*, T72* and T120* (*+/- 6 hours) after surgery. ;Timepoint(s) of evaluation of this end point: preoperatively, 6 hours after surgery and T24*, T72* and T120* (*+/- 6 hours) after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Postoperative inflammatory responses (IL-6, TNT) Change in plasma Syndecain-1, plasma soluble thrombomodulin (sTM)(CD141), plasma sE-Selectin (CD62E) and vascular endothelial growth factor (VEGF), qSOFA score, assessed once preoperatively and 4 times daily during the first 5 postoperative days Fluid distribution, both intravascular (via stroke volume(SV) guided resuscitation) and extravascular (full body water via bioelectrical impedance vector analysis) Pulmonary function during the perioperative period by Peak Expiratory Flow measurements Postoperative need for antiemetic and analgesic beyond standard course Fatigue + mobilization, assessed by the physical therapists daily Postoperative delirium via Confusion Assessment method Postoperative resting pain measured according to Numeric Rating Scale (NRS) 30-day postoperative mortality 30-day postoperative complications Length of ICU ;Timepoint(s) of evaluation of this end point: preoperatively, 6 hours after surgery and T24*, T72* and T120* (*+/- 6 hours) after surgery. | — |
Countries
Denmark
Contacts
Public ContactResearch Group, Dept. of Anesthesia
Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Capital Region of Denmark
Outcome results
None listed