Sepsis Clinical Trial
Official title:
The Effects of Preoperative High-dose Dexamethasone on Inflammatory Response and Recovery After Emergency Laparotomy, a Randomized, Double-blind, Placebo-controlled Clinical Trial - AHA STEROID TRIAL
Verified date | December 2022 |
Source | Copenhagen University Hospital, Hvidovre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this trial is to evaluate the effect of high-dose glucocorticoid on inflammatory response and recovery after emergency laparotomy in participants with intestinal obstruction and perforated viscus. Primary outcome is the reduction of C-reactive protein on postoperative day 1. Secondary outcomes are organ specific complications in the post anaesthesia phase, endothel and inflammatory markers, fluid status, preload dependency, pain, lung function, nausea and mobilization during the first 5 days after surgery, . The investigators hypothesize, that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 9, 2022 |
Est. primary completion date | October 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology: 1. Primary perforated viscus (perforated ulcer, small intestine or colon) 2. Primary intestinal obstruction ( small intestine or colon) 2. Provided verbal and written informed consent 3. Must speak and understand the Danish language 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 - |
Country | Name | City | State |
---|---|---|---|
Denmark | Mirjana Cihoric | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Mirjana Cihoric |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | changes in postoperative inflammatory responses (IL-6, TNF alfa) | Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5 | ||
Other | Change in plasma Syndecain-1sE-Selectin (CD62E) | Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5 | ||
Other | Change in plasma soluble thrombomodulin (sTM)(CD141) | Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5 | ||
Other | Change in plasma sE-Selectin (CD62E) | Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5 | ||
Other | Change in vascular endothelial growth factor (VEGF) | 0 to 1 point: Not high risk; 2 to 3 points: High risk | Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5 | |
Other | quick Sequential Organ Failure Assessment score, qSOFA | Assessed once preoperatively and 4 times daily during the first 5 postoperative days | ||
Other | Preload dependency via stroke volume(SV) guided resuscitation | Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5 | ||
Other | Fluid distribution, full body water via bioelectrical impedance vector analysis | Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5 | ||
Other | Peak flow measurements | Once a day on postoperative day 1,3 and 5 | ||
Other | Postoperative need for antiemetic and analgesic beyond standard course | Once a day during the the first 5 postoperative days | ||
Other | Mobilization, The Cumulated Ambulation Score (CAS) | The CAS describes the patient's independence with regard to three activities (getting in and out of bed, sit-to-stand-to-sit from a chair, and walking). Each activity is assessed on a three-point ordinal scale from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed) resulting in a total daily CAS score ranging from zero to six | Once a day on postoperative day 1,3 and 5 | |
Other | Postoperative delirium via Confusion Assessment method scale | 1.a: Acute onset
1b: Fluctuating course, 2: inattention 3: disorganized thinking 4: altered level of conciosness At least one criterion must be met for a positive result |
Once a day during the the first 5 postoperative days | |
Other | Postoperative resting pain measured according to Numeric Rating Scale (NRS) | 0-10 where 0 is no pain and 10 is the worst pain imaginable | 6 hours after surgery as well as once a day one postoperative day 1,3 and 5 | |
Other | Postoperative pain during mobilization, measured according to Numeric Rating Scale (NRS) | 0-10 where 0 is no pain and 10 is the worst pain imaginable | 6 hours after surgery as well as once one postoperative day 1,3 and 5 | |
Other | 30-day postoperative mortality | 30 days | ||
Other | 90-day postoperative mortality | 90 days | ||
Other | 30-day postoperative complications | 30 days | ||
Other | Length of ICU stay | 30 days | ||
Other | Overall hospital stay | 30 days | ||
Other | Plasma NO-bioavailability (L-arginine, asymmetric dimethylarginine) | preoperatively, 6 hours after surgery as well as once one postoperative day 1,3 and 5 | ||
Primary | plasma C-reactive protein | 24* hours (*+/- 6 hours) after surgery. | ||
Secondary | changes in plasma C-reactive protein | Preoperatively, 6 hours postoperatively, as well as postoperative day 3 and 5 |
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