Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

NCT01974466 | Unknown DMC

• 1 other identifier: RJpancreatitis01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatitis

Keywords

pancreatitis; resuscitation goal

Outcome Measures

Primary Outcomes (1)

• Mortality

  28day

Secondary Outcomes (1)

• intra-abdominal Hypertension

  7 days

Other Outcomes (1)

• respiratory failure

  14days

Study Arms (2)

Goal A

ACTIVE COMPARATOR

controled fluid therapy: 5\~10ml/kg/hr fulfillment of two or more of four criteria: 1. heart rate \<120 beats/min, 2. mean arterial blood pressure 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. Hematocrit ≤35%.

Other: Goal A

Goal B

OTHER

controled fluid therapy: 5\~10ml/kg/hr fulfillment of all of the following criteria: 1 central venous pressure8-12 mmHg , 2.mean arterial pressure 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70%

Other: Goal B

Interventions

Goal A OTHER

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%.

Also known as: Ruijin pancreatitis goal

Goal A

Goal B OTHER

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%

Also known as: Sepsis goal

Goal B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Ruijin Hospital: lead
• RenJi Hospital: collaborator

Study Sites (1)

Ruijin

Shanghai, Shanghai Municipality, 20000, China

RECRUITING

Related Publications (1)

• Mao EQ, Tang YQ, Fei J, Qin S, Wu J, Li L, Min D, Zhang SD. Fluid therapy for severe acute pancreatitis in acute response stage. Chin Med J (Engl). 2009 Jan 20;122(2):169-73.

  PMID: 19187641 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Qiang En Mao, PhD

  Emergency intensive care unit of Ruijin Hospital

  STUDY DIRECTOR

• Ming zhong, MD

  doctor

  STUDY CHAIR

Central Study Contacts

Zhen er Chen, PhD

CONTACT

64370045; chenerzhen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2013
• First Posted: November 1, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: August 1, 2017
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

CN (1)