Back to results

Corticosteroids to Treat Pancreatitis (CRISP)

Primary Purpose

Pancreatitis, Pancreatitis, Acute, Corticosteroid

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hydrocortisone

Placebo

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring Bedside index of severity in acute pancreatitis, Sequential Organ Failure Assessment, Randomized Controlled Trial

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrocortisone

Placebo

Arm Description

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)

Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)

Outcomes

Primary Outcome Measures

Severity of Illness Measure

Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours

Secondary Outcome Measures

Respiratory Failure Measure

Progression to Acute Respiratory Distress Syndrome (ARDS) assessed as a dichotomous variable for those patients without ARDS upon enrollment

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

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.

In-hospital mortality

Dichotomous variable that assesses whether or not the patient expired prior to hospital discharge

28-day mortality

Dichotomous variable that indicates whether or not patient expired by the 28-day time-point while enrolled in the trial.

90-day mortality

Dichotomous variable that indicates whether or not patient expired by the 90-day time-point while enrolled in the trial.

Alive and Hospital free days

Number of days in which the patient was alive and not in the hospital.

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)

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)

Full Information

NCT ID

NCT05160506

First Posted

December 7, 2021

Last Updated

November 29, 2022

Sponsor

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05160506

Brief Title

Corticosteroids to Treat Pancreatitis

Acronym

CRISP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 6, 2022 (Actual)

Primary Completion Date

January 2027 (Anticipated)

Study Completion Date

April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatitis, Pancreatitis, Acute, Corticosteroid, Hydrocortisone

Keywords

Bedside index of severity in acute pancreatitis, Sequential Organ Failure Assessment, Randomized Controlled Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hydrocortisone

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone

Other Intervention Name(s)

Cortef, Cortisol, Hydrocort

Intervention Description

Hydrocortisone is a steroid (corticosteroid) medication.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal Saline, 0.9% NACL

Intervention Description

50ml of 0.9% NACL will serve as the placebo

Primary Outcome Measure Information:

Title

Severity of Illness Measure

Description

Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours

Time Frame

Enrollment to 72 hours

Secondary Outcome Measure Information:

Title

Respiratory Failure Measure

Description

Progression to Acute Respiratory Distress Syndrome (ARDS) assessed as a dichotomous variable for those patients without ARDS upon enrollment

Time Frame

Enrollment to 28 days [truncated at 28 days]

Title

Alive and Ventilator Free Days

Description

Number of days during the 28-day period after enrollment in which the patient is alive and does not receive mechanical ventilation

Time Frame

Enrollment to 28 days [truncated at 28 days]

Title

Long-term Functional/Quality of Life Measure

Description

Scores from Short Form 36 (SF36), a validated survey used measure health-related quality of life, with higher scores indicating better quality of life.

Time Frame

90 days after Enrollment

Title

In-hospital mortality

Description

Dichotomous variable that assesses whether or not the patient expired prior to hospital discharge

Time Frame

Enrollment to 90 days [truncated at 90 days]

Title

28-day mortality

Description

Dichotomous variable that indicates whether or not patient expired by the 28-day time-point while enrolled in the trial.

Time Frame

Enrollment to 28 days [truncated at 28 days]

Title

90-day mortality

Description

Dichotomous variable that indicates whether or not patient expired by the 90-day time-point while enrolled in the trial.

Time Frame

Enrollment to 90 days [truncated at 90 days]

Title

Alive and Hospital free days

Description

Number of days in which the patient was alive and not in the hospital.

Time Frame

Enrollment to 28 days [truncated at 28 days]

Title

Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion)

Description

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)

Time Frame

Enrollment to 72 hours

Title

Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score

Description

Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by BISAP scores into two groups (BISAP ≥3; BISAP < 3)

Time Frame

Enrollment to 72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Donnino, MD

Phone

6177542295

mdonnino@bidmc.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Katherine Berg, MD

kberg@bidmc.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Donnino, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeremy Silverman

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33251516

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.

Results Reference

background

PubMed Identifier

32809003

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.

Results Reference

background

PubMed Identifier

27038920

Citation

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.

Results Reference

background

Learn more about this trial

Corticosteroids to Treat Pancreatitis

We'll reach out to this number within 24 hrs