Corticosteroids to Treat Pancreatitis

Официальное название

Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study

Обзор

This research is being done to determine if the administration of a short course of intravenous hydrocortisone, an anti-inflammatory medication, to patients with severe acute pancreatitis will improve their clinical outcomes and decrease the length of hospitalization. We think that because inflammation in the body drives the progression of pancreatitis, giving a short course of intravenous hydrocortisone may mitigate disease progression and improve clinical outcomes in patients with severe acute pancreatitis.

Подробное описание

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous hydrocortisone on clinical outcomes in patients with severe acute pancreatitis. The interventional drug is Hydrocortisone (100 mg of hydrocortisone in 50 milliliters of saline solution). The placebo is saline and is identical in appearance and volume to the interventional drug. Study drug will be administered intravenously every 8 hours for 72 hours as per standard clinical procedures by nursing staff. The patient's sequential organ failure assessment score (SOFA) will be assessed for changes over time. Blood will be drawn at several time points to assess biomarkers over time.

Вмешательства

• Препарат Hydrocortisone
  Hydrocortisone is a steroid (corticosteroid) medication.
• Препарат Placebo
  50ml of 0.9% NACL will serve as the placebo

Первичные конечные точки

• Severity of Illness Measure [Срок оценки: Enrollment to 72 hours]

Вторичные конечные точки (9)

• Respiratory Failure Measure [Срок оценки: Enrollment to 28 days [truncated at 28 days]]
• Alive and Ventilator Free Days [Срок оценки: Enrollment to 28 days [truncated at 28 days]]
• Long-term Functional/Quality of Life Measure [Срок оценки: 90 days after Enrollment]
• In-hospital mortality [Срок оценки: Enrollment to 90 days [truncated at 90 days]]
• 28-day mortality [Срок оценки: Enrollment to 28 days [truncated at 28 days]]
• 90-day mortality [Срок оценки: Enrollment to 90 days [truncated at 90 days]]
• Alive and Hospital free days [Срок оценки: Enrollment to 28 days [truncated at 28 days]]
• Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion) [Срок оценки: Enrollment to 72 hours]
• Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score [Срок оценки: Enrollment to 72 hours]

Критерии участия

Критерии включения

• Adult (≥18 years)
• Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal.
• Admission or planned admission to an intensive care unit
• SOFA disease severity score ≥3 (or at least 3 points above a known baseline)

Критерии исключения

• Known diagnosis of autoimmune pancreatitis
• Existing clinical indication for corticosteroids at a dose >5mg of oral prednisone daily (or equivalent)
• Contraindication to receiving corticosteroids
• Protected populations (prisoners)
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Beth Israel Deaconess Medical Center — Boston

Публикации

• Grossestreuer AV, Moskowitz A, Andersen LW, Holmberg MJ, Konacki V, Berg KM, Chase M, Cocchi MN, Donnino MW. Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Health-Related Quality of Life in Sepsis. Crit Care Explor. 2020 Nov 23;2(12):e0270. doi: 10.1097/CCE.0000000000000270. eCollection 2020 Dec. PMID 33251516
• Moskowitz A, Huang DT, Hou PC, Gong J, Doshi PB, Grossestreuer AV, Andersen LW, Ngo L, Sherwin RL, Berg KM, Chase M, Cocchi MN, McCannon JB, Hershey M, Hilewitz A, Korotun M, Becker LB, Otero RM, Uduman J, Sen A, Donnino MW; ACTS Clinical Trial Investigators. Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial. JAMA. 2020 Aug 1 PMID 32809003
• Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center's Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3; PMID 27038920
• Vine J, Berlin N, Moskowitz A, Berg KM, Liu X, Balaji L, Donnino MW, Grossestreuer AV. Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) protocol and statistical analysis plan: a prospective, multicentre, double-blind, randomized, placebo controlled clinical trial. Contemp Clin Trials. 2024 Apr;139:107486. doi: 10.1016/j.cct.2024.107486. Epub 2024 Feb 29. PMID 38431131

Идентификаторы

NCT: NCT05160506 · 2021P-000803

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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