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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocortisone | Experimental | Patients in this arm will be administered 100 mg of hydrocortisone in 50 milliliters of saline solution by nursing staff every 8 hours for 72 hours as per standard clinical procedures (9 administrations) |
|
| Placebo | Placebo Comparator | Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone | Drug | Hydrocortisone is a steroid (corticosteroid) medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Illness Measure | Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours | Enrollment to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Failure Measure | Progression to Acute Respiratory Distress Syndrome (ARDS) assessed as a dichotomous variable for those patients without ARDS upon enrollment | Enrollment to 28 days [truncated at 28 days] |
| Alive and Ventilator Free Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Donnino, MD | Contact | 6177542295 | mdonnino@bidmc.harvard.edu | |
| Katherine Berg, MD | Contact | kberg@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Donnino, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33251516 | Background | 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. | |
| 32809003 | Background |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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The hydrocortisone and placebo solutions are identical in appearance/volume. Only the research pharmacist, (not a member of either the research or clinical teams) will have access to the treatment allocations to ensure blinding of the investigators and clinical staff.
| Placebo | Drug | 50ml of 0.9% NACL will serve as the placebo |
|
|
Number of days during the 28-day period after enrollment in which the patient is alive and does not receive mechanical ventilation
| Enrollment to 28 days [truncated at 28 days] |
| Long-term Functional/Quality of Life Measure | Scores from Short Form 36 (SF36), a validated survey used measure health-related quality of life, with higher scores indicating better quality of life. | 90 days after Enrollment |
| In-hospital mortality | Dichotomous variable that assesses whether or not the patient expired prior to hospital discharge | Enrollment to 90 days [truncated at 90 days] |
| 28-day mortality | Dichotomous variable that indicates whether or not patient expired by the 28-day time-point while enrolled in the trial. | Enrollment to 28 days [truncated at 28 days] |
| 90-day mortality | Dichotomous variable that indicates whether or not patient expired by the 90-day time-point while enrolled in the trial. | Enrollment to 90 days [truncated at 90 days] |
| Alive and Hospital free days | Number of days in which the patient was alive and not in the hospital. | Enrollment to 28 days [truncated at 28 days] |
| Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion) | Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by survival likelihood per physician opinion into three subgroups (likely, unlikely, or uncertain) | Enrollment to 72 hours |
| Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score | Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by BISAP scores into two groups (BISAP ≥3; BISAP < 3) | Enrollment to 72 hours |
| 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 18;324(7):642-650. doi: 10.1001/jama.2020.11946. |
| 27038920 | Background | 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;20:82. doi: 10.1186/s13054-016-1257-x. |
| 38431131 | Derived | 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |