Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01974466

Enrollment

Registered

2013-11-01

Start date

2013-08-31

Completion date

2017-08-31

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatitis

Keywords

pancreatitis, resuscitation goal

Brief summary

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

Detailed description

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.

Interventions

OTHERGoal A

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%.

OTHERGoal B

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%

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mortality	28day

Secondary

Measure	Time frame
intra-abdominal Hypertension	7 days

Other

Measure	Time frame
respiratory failure	14days

Countries

China

Contacts

Primary ContactZhen er Chen, PhD

chenerzhen@hotmail.com64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026