Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) protocol and statistical analysis plan : a prospective, multicentre, double-blind, randomized, placebo controlled clinical trial
Copyright © 2024 Elsevier Inc. All rights reserved..
INTRODUCTION: Acute pancreatitis is a common disease which, in its severe form, is associated with significant morbidity and mortality. Currently, there is no specific therapy known to attenuate organ failure in severe pancreatitis and treatment consists primarily of supportive care. Corticosteroids have been shown to be beneficial in disease processes associated with systemic inflammation and could potentially improve outcomes in severe acute pancreatitis.
METHODS: The Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) trial is a multi-centre, double-blind, randomized, placebo-controlled clinical trial that aims to determine the impact of corticosteroids versus placebo on organ injury in patients with severe acute pancreatitis. Patients are randomized to receive 100 mg of hydrocortisone parenterally versus matching placebo every 8 h for 3 days. Clinical and laboratory data are collected at the time of study enrollment, at 24, 48 and 72 h. The primary end-point for the trial is the difference in 72-h change in the Sequential Organ Failure Assessment (SOFA) score between hydrocortisone and placebo groups. Additional key secondary outcomes include ventilator free days and 28-day mortality.
DISCUSSION: This study will add to the evidence base in the treatment of severe acute pancreatitis. The results will inform clinical practice and future studies in the field. Trial registration number The trial is registered on clinicaltrials.gov (NCT05160506). It was posted on December 16th, 2021. The study protocol was approved by the Beth Israel Deaconess Medical Center Committee on Clinical Investigation (CCI) (protocol 2021 P-000803).
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:139 |
|---|---|
| Enthalten in: |
Contemporary clinical trials - 139(2024) vom: 29. März, Seite 107486 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Vine, Jacob [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Acute pancreatitis |
|---|
| Anmerkungen: |
Date Completed 25.03.2024 Date Revised 25.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT05160506 Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.cct.2024.107486 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM369210026 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM369210026 | ||
| 003 | DE-627 | ||
| 005 | 20240325235036.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240304s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.cct.2024.107486 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1346.xml |
| 035 | |a (DE-627)NLM369210026 | ||
| 035 | |a (NLM)38431131 | ||
| 035 | |a (PII)S1551-7144(24)00060-0 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Vine, Jacob |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) protocol and statistical analysis plan |b a prospective, multicentre, double-blind, randomized, placebo controlled clinical trial |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 25.03.2024 | ||
| 500 | |a Date Revised 25.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05160506 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 Elsevier Inc. All rights reserved. | ||
| 520 | |a INTRODUCTION: Acute pancreatitis is a common disease which, in its severe form, is associated with significant morbidity and mortality. Currently, there is no specific therapy known to attenuate organ failure in severe pancreatitis and treatment consists primarily of supportive care. Corticosteroids have been shown to be beneficial in disease processes associated with systemic inflammation and could potentially improve outcomes in severe acute pancreatitis | ||
| 520 | |a METHODS: The Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) trial is a multi-centre, double-blind, randomized, placebo-controlled clinical trial that aims to determine the impact of corticosteroids versus placebo on organ injury in patients with severe acute pancreatitis. Patients are randomized to receive 100 mg of hydrocortisone parenterally versus matching placebo every 8 h for 3 days. Clinical and laboratory data are collected at the time of study enrollment, at 24, 48 and 72 h. The primary end-point for the trial is the difference in 72-h change in the Sequential Organ Failure Assessment (SOFA) score between hydrocortisone and placebo groups. Additional key secondary outcomes include ventilator free days and 28-day mortality | ||
| 520 | |a DISCUSSION: This study will add to the evidence base in the treatment of severe acute pancreatitis. The results will inform clinical practice and future studies in the field. Trial registration number The trial is registered on clinicaltrials.gov (NCT05160506). It was posted on December 16th, 2021. The study protocol was approved by the Beth Israel Deaconess Medical Center Committee on Clinical Investigation (CCI) (protocol 2021 P-000803) | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Acute pancreatitis | |
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Corticosteroids | |
| 650 | 4 | |a Critical care | |
| 650 | 4 | |a Protocol | |
| 650 | 4 | |a Statistical analysis plan | |
| 650 | 7 | |a Hydrocortisone |2 NLM | |
| 650 | 7 | |a WI4X0X7BPJ |2 NLM | |
| 700 | 1 | |a Berlin, Noa |e verfasserin |4 aut | |
| 700 | 1 | |a Moskowitz, Ari |e verfasserin |4 aut | |
| 700 | 1 | |a Berg, Katherine M |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Xiaowen |e verfasserin |4 aut | |
| 700 | 1 | |a Balaji, Lakshman |e verfasserin |4 aut | |
| 700 | 1 | |a Donnino, Michael W |e verfasserin |4 aut | |
| 700 | 1 | |a Grossestreuer, Anne V |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Contemporary clinical trials |d 2005 |g 139(2024) vom: 29. März, Seite 107486 |w (DE-627)NLM154869031 |x 1559-2030 |7 nnns |
| 773 | 1 | 8 | |g volume:139 |g year:2024 |g day:29 |g month:03 |g pages:107486 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.cct.2024.107486 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 139 |j 2024 |b 29 |c 03 |h 107486 | ||