Effect of early weight-based aggressive versus non-aggressive goal-directed fluid resuscitation in the early phase of acute pancreatitis: an open-label multicenter randomized-controlled trial - Aggressive fluid resuscitation in the acute pancreatitis

Enrique de Madaria0 sites700 target enrollmentApril 30, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 30, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Enrique de Madaria

•adult (\=18\) patients with AP according to the revision of the Atlanta classification (RAC) (Banks et al, Gut 2013\): at least 2 of the following 3 criteria: A) Typical abdominal pain, B) Increase in serum amylase or lypase levels higher than 3 times the upper limit of normality, and C) Signs of AP in imaging techniques (CT scan or MRI). This study requires signed 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 350
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 350

•non\-controlled arterial hypertension (\>160 (Systolic BP) and/or 100 mmHg (diastolic BP), heart failure (New York Hear Association Class II\-IV) or ejection fraction \<50%, decompensated cirrhosis (Child’s Class B or C), Hyper or hyponatremia (\<135 or \>145 mEq/l), hyperpotassemia (\>5 mEq/l), hypercalcemia (albumin or protein\-corrected calcium\>10\.5 mg/dl), chronic kidney failure (basal glomerular filtration rate \<60 mL/min/1\.73m2\), clinical signs of volume overload (peripheral edema, pulmonary rales, and ascites), organ failure according to the RAC (Marshall\=2\), time from pain onset to arrival to emergency room \>24h, time from confirmation of pancreatitis to randomization \>8h, severe comorbidity associated with an estimated life expectancy \<1 year and confirmed chronic pancreatitis (in case of recurrent alcoholic pancreatitis a recent (\<6 months) CT scan/MRI or endoscopic ultrasound is needed to rule out chronic pancreatitis).