- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04811755
Is TIme From adMission to surgEry an Independent Prognostic Factor for Survival of Patients With Gastro-intestinal Perforation Associated With Septic Shock: (TIME) An Italian Intersocietary Retrospective and Prospective Observational Trial (TIME)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an Italian National multicenter study composed by a retrospective phase of data collection from patients of past ten years and a perspective one of next two years.
INCLUSION AND EXCLUSION CRITERIA We include in our analysis all patients with more than 18 years old undergoing emergency surgery for gastro-intestinal perforations, with or without signs of septic shock. All patients with covered perforations or abdominal perivisceral free air bubbles treated with non- operative management or delayed surgery will be excluded. An online Case Report Form (CRF) will be filled out by every participating Italian participating center.
ENDPOINTS Primary outcome analyzed is in-hospital Clavien-Dindo > 3 complication rate [12]. Secondary outcomes are 60-d mortality rate, total length of stay (LOS), LOS in Intensive Care Unit (ICU), days of mechanical ventilation, re-intervention rate and 30-d readmission rate.
Analyzed variables are:
- Hospital characteristics; teaching/non-teaching setting; I/II level ED; emergency surgery/volume x year; 24H/on-call radiology and surgery team; presence of a dedicated OR in ED;
- Patient demographics (gender, age, Body Mass Index (BMI) and American Society of Anaesthesiologists' (ASA) classification of Physical Health, medical history of past abdominal surgical operations and comorbidities according to Charlson Comorbidity Index (CCI), mainly related to corticosteroids therapy and immunosuppressive conditions),
- Patient management in ED: admission date and time; Priority code at admission; time of abdominal x-Ray; time of CT-scan; Time of patient evaluation by surgeon on- call; Preoperative resuscitation management (Y/N, type, time of beginning); presence of Sepsis (infection documented or suspected + SOFA >=2) and of septic shock (sepsis + persistent hypotension needing vasopressors to maintain a Mean Arterial Pressure (MAP) of 65 mmHg; serum values of lactates > 18 mg/dL (or 2 mmol/L) with an adequate volume resuscitation measures) at admission or during patient stay in ED; SOFA score at admission; Emergency surgery score; ACS NSQIP® Surgical Risk score.
- Radiological findings: CT-scan reports of patients selected will be analyzed by site data-collection centers with the aim to identify typical and atypical radiological findings (subdiaphragmatic free gas, free peritoneal fluid, bowel wall discontinuity, extraluminal oral contrast, extraluminal abscess, abdominal collections, fat stranding, portal venous gas, wall bowel thickening, pneumatosis and mucosal hyperenhancement).
- Surgery: Time of skin incision; Type and duration of surgery; source control surgery, Open Abdomen; surgical approach; site and cause of perforation; pathologic data; Emergency surgery score; ACS NSQIP® Surgical Risk score.
- Postoperative Course: Preoperative mortality (patients die before surgery); Medical and Surgical complications (Clavien-Dindo score); total LOS; LOS in ICU; days of Mechanical Ventilation; Re-intervention rate; 90-d mortality.
PLANNED SAMPLE SIZE With a binary response variable, β=0·95, α=0·05, an anticipated small effect size and an allocation ratio 1:10 (Early treatment Yes vs. No), it has been calculated that 3276 patients are required to detect an association between the variables and the endpoint.
PLANNED ANALYSES Time between patient admission to ED and surgery will be analyzed as a continuous variable with t-Student's tests, comparing means between the different outcomes (primary and secondary). Different cut-off will be tested to define a significant time threshold correlating with outcomes. If necessary, more time intervals will be evaluated to evaluate correlations between the variables collected and the time.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- more than 18 years old
- emergency surgery for gastro-intestinal perforations
- with or without signs of septic shock
Exclusion Criteria:
- All patients with covered perforations or abdominal perivisceral free air bubbles treated with non- operative management
- delayed surgery
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
in-hospital Clavien-Dindo > 3 complication rate
Time Frame: up to 90 days after surgery
|
up to 90 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
90-d mortality rate
Time Frame: up to 90 days after surgery
|
up to 90 days after surgery
|
total length of stay (LOS)
Time Frame: up to 90 days after surgery
|
up to 90 days after surgery
|
LOS in Intensive Care Unit (ICU)
Time Frame: up to 90 days after surgery
|
up to 90 days after surgery
|
days of mechanical ventilation
Time Frame: up to 90 days after surgery
|
up to 90 days after surgery
|
re-intervention rate
Time Frame: up to 90 days after surgery
|
up to 90 days after surgery
|
30-d readmission rate
Time Frame: up to 30 days after surgery
|
up to 30 days after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
- Sartelli M, Viale P, Catena F, Ansaloni L, Moore E, Malangoni M, Moore FA, Velmahos G, Coimbra R, Ivatury R, Peitzman A, Koike K, Leppaniemi A, Biffl W, Burlew CC, Balogh ZJ, Boffard K, Bendinelli C, Gupta S, Kluger Y, Agresta F, Di Saverio S, Wani I, Escalona A, Ordonez C, Fraga GP, Junior GA, Bala M, Cui Y, Marwah S, Sakakushev B, Kong V, Naidoo N, Ahmed A, Abbas A, Guercioni G, Vettoretto N, Diaz-Nieto R, Gerych I, Trana C, Faro MP, Yuan KC, Kok KY, Mefire AC, Lee JG, Hong SK, Ghnnam W, Siribumrungwong B, Sato N, Murata K, Irahara T, Coccolini F, Segovia Lohse HA, Verni A, Shoko T. 2013 WSES guidelines for management of intra-abdominal infections. World J Emerg Surg. 2013 Jan 8;8(1):3. doi: 10.1186/1749-7922-8-3.
- Azuhata T, Kinoshita K, Kawano D, Komatsu T, Sakurai A, Chiba Y, Tanjho K. Time from admission to initiation of surgery for source control is a critical determinant of survival in patients with gastrointestinal perforation with associated septic shock. Crit Care. 2014 May 2;18(3):R87. doi: 10.1186/cc13854.
- Buck DL, Vester-Andersen M, Moller MH; Danish Clinical Register of Emergency Surgery. Surgical delay is a critical determinant of survival in perforated peptic ulcer. Br J Surg. 2013 Jul;100(8):1045-9. doi: 10.1002/bjs.9175.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TT.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emergency Surgery
-
University of Milano BicoccaCompletedEnhanced Recovery After Surgery | Emergency SurgeryItaly
-
Shenzhen People's HospitalUnknown
-
University of Wisconsin, MadisonNational Institute on Aging (NIA)Recruiting
-
Methodist Health SystemCompleted
-
University Hospital, GenevaCompletedEmergency General Surgery
-
Copenhagen University Hospital at HerlevZealand University Hospital; University of Copenhagen; Bispebjerg Hospital; Herning... and other collaboratorsTerminatedEmergency Abdominal SurgeryDenmark
-
Centre Hospitalier Universitaire, AmiensRecruitingMortality | Emergency SurgeryFrance
-
Ospedale Misericordia e DolceUnknownWound Healing | Negative-Pressure Wound Therapy | Emergency Abdominal Surgery | Prevena | Dirty Abdominal Surgery | Contaminated Abdominal SurgeryItaly
-
Samuel Lunenfeld Research Institute, Mount Sinai...Not yet recruitingPulmonary Aspiration | Emergency Surgery
-
Lionel BouvetCompletedEmergency Surgery | Full StomachFrance
Clinical Trials on Surgical timing from ED admission to surgery
-
Fundació Institut de Recerca de l'Hospital de la...Fundació Ictus; Pla Director de la Malaltia vascular Cerebral, Departament...UnknownIntracerebral HemorrhageSpain
-
Abant Izzet Baysal UniversityCompletedOccupational Health | Volatile Organic Compounds | Air QualityTurkey
-
Xijing HospitalRecruitingCOVID-19 | Postoperative Complications | SurgeryChina
-
David BrunkColorado Cardiac AllianceRecruitingCognitive Impairment | Atrial Fibrillation | Cognitive Change | Executive Dysfunction | Cognitive Symptom | Cognitive Impairment, MildUnited States
-
Istituto Clinico HumanitasZeta Research LtdUnknown
-
Campus Bio-Medico UniversityRecruiting
-
Shanghai 10th People's HospitalCompleted
-
Case Comprehensive Cancer CenterCompletedBreast CancerUnited States
-
AO Clinical Investigation and Publishing DocumentationTerminatedSingle Level Stable Thoracolumbar Fracture Type AO A3 | Multiple Level Stable Thoracolumbar Fracture Type AO A3Brazil, Germany, Chile, Czechia, Italy, Portugal
-
Rennes University HospitalNot yet recruitingHysterectomies for Low- or Intermediate-risk Endometrial CarcinomaFrance