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Balanced Crystalloid Solutions for Acute Pancreatitis

NCT ID: NCT04688645

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2023-02-01

Brief Summary

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Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.

Detailed Description

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Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Balanced crystalloid solution

Balanced crystalloid solution - Plasmalyte.

Group Type EXPERIMENTAL

Balanced crystalloid solution

Intervention Type DRUG

Balanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.

Normal saline

0.9% sodium chloride solution.

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.

Interventions

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Balanced crystalloid solution

Balanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.

Intervention Type DRUG

Normal saline

0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.

Intervention Type DRUG

Other Intervention Names

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Plasmalyte; balanced crystalloids Saline; 0.9% sodium chloride solution

Eligibility Criteria

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Inclusion Criteria

\- patients diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis

Exclusion Criteria

* chronic pancreatitis
* liver cirrhosis (Child-Pugh B and C)
* chronic hearth failure (NYHA\>II)
* acute coronary syndrome
* cardiovascular intervention within 60 days before randomization
* chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease
* chronic kidney disease (eGFR \<30 ml/min/1.73 m2)
* concomitant biliary infection (cholecystitis, cholangitis)
* severe autoimmune disease
* chronic active infection (TBC, AIDS)
* metastatic malignant disease
* primary pancreatic neoplasm
* patients transferred from other hospitals
* pregnancy and ongoing breastfeeding
* not willing to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rijeka

OTHER

Sponsor Role collaborator

University Hospital Rijeka

OTHER

Sponsor Role lead

Responsible Party

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Goran Poropat

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Rijeka

Rijeka, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Goran Poropat, MD, PhD

Role: CONTACT

Phone: 0038551658191

Email: [email protected]

Anja Radovan, MD

Role: CONTACT

Phone: 0038551658111

Email: [email protected]

Facility Contacts

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Goran Poropat, MD, PhD

Role: primary

Other Identifiers

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uniri-biomed-18-154

Identifier Type: -

Identifier Source: org_study_id