FLUID THERAPY IN ACUTE PANCREATITIS MedDRA version: 14.1 Level: PT Classification code 10033647 Term: Pancreatitis acute System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Ringer lactate
Product Name: RINGER LACTATO
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: sodium clorhide
Other descriptive name: SODIUM CLORHIDE
Concentration unit: mg/l
Sponsors
Hospital General Universitario de Alicante
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over 18 years Patients with first episode of acute pancreatitis Patients that accept to participate in the trial signing the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: -History of severe renal disease -Heart failure NYHA functional class> II -COPD with home oxygen -Suspected or confirmed active infection -Sodium Deric Hypernatremia > 1 mEq / L or hyponatremia (<135 mEq / L) -Rhabdomyolysis -Onset of pain more than 24 hours - Metastatic neoplasia - Active inflammatory bowel disease - Autoimmune disease - Active chronic infection (AIDS, tuberculosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the incidence of systemic inflammatory response syndrome and the degree of elevation of CRP at 48-72 hours in patients with acute pancreatitis treated with saline versus Ringer's lactate during the first 72 hours of hospitalization;Secondary Objective: To evaluate the incidence of local complications (pancreatic necrosis, acute and collections) To evaluate the incidence of organ failure Rate of hospital stay Assess need for ICU admission;Primary end point(s): -Compliance criteria for systemic inflammatory response syndrome (SIRS) from the 24 hours of admission -SIRS criteria compliance date. -Days until SIRS criteria compliance - C-reactive protein in blood at 48 and 72 hours;Timepoint(s) of evaluation of this end point: 24,48, 72 hours 7 days hospital discharged | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Severity of acute pancreatitis -Development of pancreatic necrosis, acute collections and organ failure -Hospital stay in days -Need for ICU admission and duration;Timepoint(s) of evaluation of this end point: At hospital discharge | — |
Countries
Spain
Contacts
Public ContactEnrique de Madaria Pascual
Hospital General de Alicante
Outcome results
None listed