Clinical Trial Results:
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
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Summary
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EudraCT number |
2020-002586-34 |
Trial protocol |
DK |
Global end of trial date |
02 Jan 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Jun 2025
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First version publication date |
18 Jun 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
STEROID_MC_1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04791566 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Research Group, Dept. of Anesthesia
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Sponsor organisation address |
Kettegard alle 30, Hvidovre, Denmark, 2650
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Public contact |
Research Group, Dept. of Anesthesia, Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Capital Region of Denmark , mirjana.cihoric.03@regionh.dk
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Scientific contact |
Research Group, Dept. of Anesthesia, Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Capital Region of Denmark , 0045 38620547, mirjana.cihoric.03@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Jan 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Jan 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Jan 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
C-reactive protein T24H after surgery.
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Protection of trial subjects |
No protection measures put in place-
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Mar 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 120
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Worldwide total number of subjects |
120
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EEA total number of subjects |
120
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
48
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From 65 to 84 years |
63
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85 years and over |
9
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Recruitment
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Recruitment details |
After a confirmed CT diagnosis of either intestinal obstruction or perforated viscus, the senior surgeon contacted the primary investigator (PI). The PI evaluated and informed the patients, securing written and verbal consent before surgery and before arrival at the operating room. The PI of the trial evaluated and included all patients. | |||||||||
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Pre-assignment
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Screening details |
Adult patients scheduled for emergency laparotomy for either intestinal obstruction or perforated viscus were eligible. Exclusion criteria were reoperations, traumas, gynaecological, urogenital, and other vascular pathology, dementia, insulin treatment for diabetes, immunolsuppresive treatment, allergy, pregnancy and lack of informed consent. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||
Blinding implementation details |
Sequence generation and preparation of 120 sequentially numbered opaque sealed randomization envelopes were completed by two people independent of the research team and who had no further role in the trial. Personnel, not otherwise involved in the trial opened the randomization envelopes, prepared and blinded the trial medication, and sealed the envelopes again afterwards. Patients, care providers, and data collectors were blinded to allocation.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Dexamethasone | |||||||||
Arm description |
A single preoperative dose of 1 mg/kg dexamethasone diluted in 100 ml of physiological saline and administered just after anaesthesia induction as a 15-min infusion. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
dexamethasone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Dexamethasone 10.0 mg/mL (Ratiopharm, Germany) . Patients will receive 1 mg/kg Dexamethasone.
Dispensed as Dexamethasone-21-dihydrogenfosfat, diluted in normal saline, with a total volume of 100 mL.
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Arm title
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Placebo arm | |||||||||
Arm description |
A single preoperative dose of 1 mg/kg of placebo (saline), diluted in 100 ml of physiological saline and administered just after anaesthesia induction as a 15-min infusion. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Bolus infusion of normal saline, 100 mL over a 10-15-minute period in addition to standard care (no steroid treatment).
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Baseline characteristics reporting groups
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Reporting group title |
Dexamethasone
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Reporting group description |
A single preoperative dose of 1 mg/kg dexamethasone diluted in 100 ml of physiological saline and administered just after anaesthesia induction as a 15-min infusion. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo arm
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Reporting group description |
A single preoperative dose of 1 mg/kg of placebo (saline), diluted in 100 ml of physiological saline and administered just after anaesthesia induction as a 15-min infusion. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Dexamethasone
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Reporting group description |
A single preoperative dose of 1 mg/kg dexamethasone diluted in 100 ml of physiological saline and administered just after anaesthesia induction as a 15-min infusion. | ||
Reporting group title |
Placebo arm
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Reporting group description |
A single preoperative dose of 1 mg/kg of placebo (saline), diluted in 100 ml of physiological saline and administered just after anaesthesia induction as a 15-min infusion. | ||
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End point title |
CRP at T24 hours after surgery | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At 24 hours after surgery, overall cohort
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Statistical analysis title |
chi sqare | ||||||||||||
Comparison groups |
Dexamethasone v Placebo arm
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Number of subjects included in analysis |
112
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Confidence interval |
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End point title |
CRP at T24 hours after surgery, intestinal obstruction | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At 24 hours after surgery, intestinal obstruction
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Statistical analysis title |
chi square | ||||||||||||
Comparison groups |
Dexamethasone v Placebo arm
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Number of subjects included in analysis |
56
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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End point title |
30 day mortality | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
30 day postoperatively
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| No statistical analyses for this end point | ||||||||||
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End point title |
90 day mortality | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
90 day postoperatively
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| No statistical analyses for this end point | ||||||||||
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End point title |
30 day postoperative complications | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
30 days postoperatively
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| No statistical analyses for this end point | ||||||||||
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End point title |
LOS | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Length of in-hospital stay
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| No statistical analyses for this end point | |||||||||||||
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End point title |
CRP at T24 hours after surgery, perforated viscus | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At 24 hours after surgery, perforated viscus
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Variables registered daily during admission for the first 14 days after randomization
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
within protocol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Dexamethasone
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Reporting group description |
A single preoperative dose of 1 mg/kg dexamethasone diluted in 100 ml of physiological saline and administered just after anaesthesia induction as a 15-min infusion. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
A single preoperative dose of 1 mg/kg of placebo (saline), diluted in 100 ml of physiological saline and administered just after anaesthesia induction as a 15-min infusion. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
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Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/39028763 |
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