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PancreatitisPhase 2CRISPNCT05160506

Corticosteroids to Treat Pancreatitis

A Phase 2 study testing Hydrocortisone in people with Pancreatitis and Pancreatitis, Acute, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Pancreatitis, Pancreatitis, Acute, Corticosteroid
What is being tested?
Hydrocortisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteUnited States
Study dates
6 Mar 2022to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Donnino, MD contact

6177542295

mdonnino@bidmc.harvard.edu

Katherine Berg, MD contact

kberg@bidmc.harvard.edu

United States1 site, 1 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Jeremy Silverman

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Hydrocortisone, Placebo
Keywords
Bedside index of severity in acute pancreatitis, Sequential Organ Failure Assessment, Randomized Controlled Trial
Medical subject headings
Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydrocortisoneDrug

    Also called Cortef, Cortisol, Hydrocort

    Hydrocortisone is a steroid (corticosteroid) medication.

  • PlaceboDrug

    Also called Normal Saline, 0.9% NACL

    50ml of 0.9% NACL will serve as the placebo

Study groups in NCT05160506
Study groupRoleWhat they receive
HydrocortisoneExperimentalPatients 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)
Receives: Drug: Hydrocortisone
PlaceboPlacebo comparatorPatients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severity of Illness Measure

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

    Measured: Enrollment to 72 hours

Secondary outcomes (9)

  1. Respiratory Failure Measure

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

    Measured: Enrollment to 28 days [truncated at 28 days]

  2. 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

    Measured: Enrollment to 28 days [truncated at 28 days]

  3. 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.

    Measured: 90 days after Enrollment

  4. In-hospital mortality

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

    Measured: Enrollment to 90 days [truncated at 90 days]

  5. 28-day mortality

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

    Measured: Enrollment to 28 days [truncated at 28 days]

  6. 90-day mortality

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

    Measured: Enrollment to 90 days [truncated at 90 days]

  7. Alive and Hospital free days

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

    Measured: Enrollment to 28 days [truncated at 28 days]

  8. 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)

    Measured: Enrollment to 72 hours

  9. 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)

    Measured: Enrollment to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start6 Mar 2022
  3. Primary completionJan 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160506
Sponsor's protocol ID
2021P-000803
Acronym
CRISP
Status last verified
Feb 2026
First submitted
7 Dec 2021
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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 18;324(7):642-650. doi: 10.1001/jama.2020.11946.

    PubMed 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;20:82. doi: 10.1186/s13054-016-1257-x.

    PubMed 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.

    PubMed 38431131

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydrocortisone in people with Pancreatitis and Pancreatitis, Acute, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Donnino, MD (6177542295, mdonnino@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of Illness Measure (time frame: Enrollment to 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05160506, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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