Acute PAncreatitis and Home Care vs. Hospital Admission Study (PADI_2)

April 29, 2022 updated by: Elena Ramírez-Maldonado

Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Home Care vs Hospital Admission in Patients With Acute Pancreatitis

Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction.

With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology.

Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is prospective, randomized, controlled, multicentre trial.

OBJECTIVES

Primary objective Compare the results of 3 different strategies for the management of patients with mild acute pancreatitis (AP) and to analyze differences in satisfaction patients and economic costs.

METHODS

Patients with mild AP will be randomly in three groups: group A: outpatient treatment, group B: medical home care and group C: hospitalization.

The primary and several secondary endpoints will be obtained:

  1. Treatment failure rate (the primary endpoint).
  2. Serum amylase, lipase, electrolytes, BUN (blood urea nitrogen), creatinine, liver function tests, and full blood count at hospital admission, 24 hours and 72 hours.
  3. Relapse pain.
  4. Diet intolerance.
  5. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
  6. Pain and Analgesic requirement.
  7. Local complications including pancreatic necrosis, abscess, pseudocyst.
  8. Health costs
  9. Patient satisfaction

Study Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI).
  2. age > 18 years, sign consent form.

Exclusion Criteria:

  1. pregnant o breastfeeding women.
  2. abdominal pain lasting >96 horas before admission.
  3. the possibility of poor oral intake for reasons other than AP.
  4. Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction.
  5. Chronic pancreatitis.
  6. ASA ≥3.
  7. Randomization lesser the 24 hours after randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Outpatient
The Mild AP patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.
Other: Outpatient
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.
Experimental: Medical home care
The mild AP patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.
Other: Medical home care
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.
Active Comparator: Hospitalization
The mild AP patient is hospitalized
Other: Hospitalization
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is hospitalized with usual treatment (PADI_1) in each center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The treatment failure rate
Time Frame: 30 days
Treatment failure is defined as persistence, increase or recurrence of abdominal pain, and or intolerance diet, hospital admission, and mortality
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse of abdominal pain
Time Frame: 30 days
Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain
30 days
Diet tolerance
Time Frame: 30 days
Patient can eat at least 50% of the meals
30 days
Systemic Inflammatory Response Syndrome (SIRS) Score
Time Frame: 4 days
SIRS is a simple clinical score, ranging from 0-4, that utilizes objective, routine clinical parameters (body temperature, heart rate, respiratory rate or arterial carbon dioxide tension and white blood count) that directly reflect the underlying inflammatory response. A lower change in SIRS score (negative number) indicates a better outcome (less inflammation).
4 days
Number of Participants who Development of Organ Failure
Time Frame: 4 days
Including respiratory, renal and cardiovascular failures defined as modified Marshal score of equal and greater than 2. The minimum and maximum values in the modified Marshal score for each organ failure range from 0 to 4 with a higher value representing worse outcomes.
4 days
Mortality
Time Frame: 30 days
Enrolled subjects that died. A death indicates a worse outcome.
30 days
Hospital admission
Time Frame: 30 days
The AP patient needs hospital admission due to treatment failure
30 days
Satisfaction medical / hospital care
Time Frame: 30 days
patient satisfaction is asessed comparing management with and without admittance to the hospital. Will be assessed Patient satisfaction feedback (PSF). Scale: Strongly agree, Agree, Not sure, Disagree, Strongly disagree.
30 days
Health costs
Time Frame: 30 days
The costs in euros caused by diagnosis, treatment, stay in the emergency room, complications and follow-up
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elena Ramírez-Maldonado

Collaborators

Hospital Clinic of Barcelona
Consorci Sanitari del Maresme

Investigators

  • Principal Investigator: Elena Ramírez-Maldonado, PhD, Hospital Universitari Joan XXIII
  • Principal Investigator: Rosa Jorba-Martin, PhD, Hospital Universitari Joan XXIII

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PADI_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocolo will be shared

IPD Sharing Time Frame

01/08/2022-01/01/2023

IPD Sharing Access Criteria

Pancreatic researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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