engleski

Use of balanced crytsalloid solutions in the early treatment of acute pancreatitis – protocol for a randomized controlled trial

Purpose:The aim of our trial is to assess the potential beneficial andharmful effects of a balanced crystalloid solution (Plasmayte) compared tonormal saline in the early treatment of patients with acute pancreatitis.Materials and methods:Consecutive patients with a diagnosis ofacute pancreatitis admitted at our hospital will be randomly assigned toreceive a balanced crytalloid solution as an initial bolus od 10 ml/kg bodyweight within 60 min after randomization and then continued at a rate of3.0 ml/kg body weight/h during the next 72 hours, or normal salineadministered in an identical manner. In cases of severe hypovolaemiabolus doses may be repeated and the administration offluid will becontinued at a rate of 3.5 ml/kg/h with the possibility of potential increaseto a maximum of 5.0 ml/kg/h. Clinical assessment with systemic inflam-matory response syndrome (SIRS) parameters and laboratory parametersincluding pH, bicarbonates, white blood cells count, hematocrit, blood ureanitrogen, creatinine, sodium, potassium, C-reactive protein, procalcitonin, and lactate levels will be assessed 8-12, 24, 48, and 72 hours afterrandomization.All patients (age18 years) with a diagnosis of acute pancreatitisdefined according to the Revised Atlanta criteria, regardless of etiology andseverity of disease, who present at our hospital within 48 hours from onsetof symptoms will be included in the trial. Exclusion criteria: chronicpancreatitis, liver cirrhosis (Child-Pugh B and C), chronic hearth failure(NYHA>II), acute coronary syndrome, cardiovascular intervention within60 days before randomization, COPD on home oxigenator or acute exac-erbation of COPD, chronic kidney disease (eGFR<30 ml/min/1.73m2), concomitant biliary tract infection (acute cholecystitis, acute cholangitis), severe autoimmune disease, chronic active infection (TBC, AIDS), meta-static malignancy, primary pancreatic neoplasms, patients transfered fromother hospitals, pregnant and breasfeeding women.We will assess incidence of SIRS as the primary outcome. Secondaryoutcome measures will be mortality, organ failure (persistent and transi-tory), local complications, infected pancreatic necrosis, need for endo-scopic, percutaneous, and surgical interventions, and length of hospitalstay.

Acute pancreatitis, crystalloids, resuscitation

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