Corticosteroids to Treat Pancreatitis

Pancreatitis Clinical Trial

— CRISP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160506
• Other study ID #: 2021P-000803
• Status: Recruiting
• Phase: Phase 2
• Start date: March 6, 2022
• Est. completion date: April 2027

Study information

• Verified date: November 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: Michael Donnino, MD
• Phone: 6177542295
• Email: mdonnino[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: April 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Adult (=18 years)

2. Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level =3x the upper limit of normal.

3. Admission or planned admission to an intensive care unit

4. SOFA disease severity score =3 (or at least 3 points above a known baseline)

Exclusion Criteria:

1. Known diagnosis of autoimmune pancreatitis

2. Existing clinical indication for corticosteroids at a dose >5mg of oral prednisone daily (or equivalent)

3. Contraindication to receiving corticosteroids

4. Protected populations (prisoners)

5. Pregnancy

Related Conditions & MeSH terms

• Corticosteroid
• Hydrocortisone
• Pancreatitis
• Pancreatitis, Acute

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Illness Measure	Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours	Enrollment to 72 hours
Secondary	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]
Secondary	Alive and Ventilator Free Days	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]
Secondary	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
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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
Secondary	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