Balanced Crystalloid Solutions for Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688645
• Other study ID #: uniri-biomed-18-154
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2020
• Source: University Hospital Rijeka
• Contact: Goran Poropat, MD, PhD
• Phone: 0038551658191
• Email: gporopat8[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Croatia	University Hospital Rijeka	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Rijeka	University of Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)	Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils.	30 days
Secondary	Mortality	Number of death cases	30 days
Secondary	Number of participants with organ failure (transitory and persistent)	Organ failure defined according to the modified Marshall criteria	30 days
Secondary	Number of participants with local complications	Local complications including: acute peripancreatic fluid collection; acute necrotic collection; pseudocyst; walled-off necrosis	30 days
Secondary	Number od participants with systemic complications	Worsening of existing concomitant diseases	30 days
Secondary	Number of participants with infected pancreatic necrosis	Defined by positive cultures from fine-needle aspiration of necrotic tissue or by the combination of clinical deterioration with clinical signs of infection and presence of gas within the necrotic tissue on imaging in cases of culture-negative, but highly suspicious cases.	30 days
Secondary	Number of participants needing endoscopic / percutaneous / surgical interventions	In cases when presence of local infection or local complications (i.e. collection compressing surrounding organs and causing symptoms) requires an intervention	30 days
Secondary	Length of hospital stay	Number of days in hospital, from admission to discharge or death.	30 days