Enhanced Recovery in Acute Pancreatitis | NCT02813876

Studies
Enhanced Recovery in Acute Pancreatitis

NCT02813876

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

46Actual

Phase

Phase 2

Conditions

Acute Pancreatitis

Interventions

Enhanced recovery protocol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

May 15, 2017Actual

Completion Date

May 15, 2017Actual

First Submitted Date

Jun 23, 2016

First Submission Date that Met QC Criteria

Jun 23, 2016

First Posted Date

Jun 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2017

Last Update Posted Date

May 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Label	Type	Description	Intervention Names
Enhanced recovery	Experimental	Enhanced recovery protocol for nursing, diet and analgesic regimen	Other: Enhanced recovery protocol
Standard care	No Intervention	Standard care arm

Name	Type	Description	Arm Group Labels	Other Names
Enhanced recovery protocol	Other		Enhanced recovery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to tolerance of oral refeeding	Resumption of intake of 50% of solid meal without symptoms of worsening post-prandial abdominal pain, nausea or vomiting	Up to 7 days

Secondary Outcomes

Measure	Description	Time Frame
Time to disease resolution	Acute Pancreatitis Clinical Activity Index score<50	Up to 30 days
Satisfaction with inpatient hospital care	Comparison of overall and pain management satisfaction score based on validated survey instrument

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging

Exclusion Criteria:

• Severe acute pancreatitis defined as the presence of any of the following:
- Organ failure (oxygen saturation<90% on room air, mean arterial pressure<70 mmHG or any requirement for vasopressor or inotropic support, serum creatinine>2.0, Glasgow coma score<15)
- Suspected or confirmed infected pancreatic necrosis: fever, leukocytosis in the setting of suspicious findings on cross-sectional imaging (gas within necrotic collection) or confirmed infection on fine needle aspirate
  - Chronic pancreatitis or any chronic pain syndrome requiring use of narcotic analgesic within 30 days prior to hospitalization
  - Abdominal surgery within 60 days prior to hospitalization
  - History of gastrointestinal motility disorder
  - Inflammatory bowel disease
  - Chronic comorbid illness including but not limited to >New York Heart Association Class II congestive heart failure, cirrhosis, oxygen-dependent chronic obstructive pulmonary disease or malignancy other than non-squamous skin cancer not in remission.
  - Documented allegy to any of the following medications: dilaudid, Tylenol
  - Patients transferred from an outside hospital for ongoing care
  - Non-English speaking patients for whom an appropriate language interpretor cannot be identified.
  - Pregnant women will be excluded from participation in this phase IIb trial given the limited projected sample size and rarity of this condition during pregnancy.
  - Minors (patients <18 years of age) will not be eligible for study inclusion. The interventions being compared in the study protocol are standard care for adult patients with acute pancreatitis. However, the safety and efficacy of these treatments in the pediatric population has not been established.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases