Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

N/AUnknownNCT01974466

Ruijin Hospital60 enrolled

Overview

To compare different goals of fluid resuscitation in early stage of acute pancreatitis

With regard to study of sepsis and several studies of SAP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission（or onset of abdominal pain）, early goal-directed fluid resuscitation has the potential of improving outcome also in SAP. But the goal of fluid resuscitation remained controversial.Several criteria of fluid resuscitation had been described. Ours had been described in previous study, and had shown a ideal result with less incidence of abdominal compartment syndrome and higher survival rate. This study aims to determine a better goal of fluid resuscitation in severe acute pancreatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pancreatitis

Interventions

Goal AOTHER

controled fluid therapy：10\~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of two or more of four criteria:1. HR \<120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT ≤35%.

Goal BOTHER

controled fluid therapy：10\~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of all of the following criteria: 1 CVP 8-12 mmHg , 2.MAP 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase 2. Onset of abdominal pain within \<=72h before admission 3. moderate severe or severe acute pancreatitis according to Atlanta criteria revisited in 2012 4. Evidence of \>= 1 predictor of fluid resuscitation: Haematocrit \>44% (male) or \>40% (female), respectively Lactate\>4mmol/L; heart rate\>120bpm; urine \<0.5ml/kg/h for 6 hour; Mean arterial pressure\>85 or \<60 mmHg Exclusion Criteria: * 1\. Pregnancy 2. New York Heart Association classification \>II 3. With pacemaker implantation 4. chronic obstructive pulmonary disease 5. chronic kidney disease 6. Pre-existing disease with life expectancy \< 3 months

Locations (1)

Ruijin

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Mortality

Time frame: 28day

Secondary Outcomes

intra-abdominal Hypertension

Time frame: 7 days

Central Contacts

Zhen er Chen, PhD

CONTACT

64370045 chenerzhen@hotmail.com

Data from ClinicalTrials.gov

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