Status:
COMPLETED
Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis
Lead Sponsor:
Technical University of Munich
Conditions:
Acute Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Acute pancreatitis (AP) is a common disorder with rising incidence varying between 35 and 80 per 100,000 in Europe and the USA. About 15% of patients develop necrotizing pancreatitis (NP) with a morta...
Detailed Description
Resuscitation using crystalloids and/or colloids with the following goals: ITBI: 850 -1000 ml/sqm, if ELWI \<=12\*ml/kg 750 - 850 ml/sqm, if ELWI \>12\*ml/kg and/or PaO2:FiO2 \<200 \*ELWI \<=12ml/kg...
Eligibility Criteria
Inclusion
- Diagnosis of pancreatitis:
- Typical pain
- Increase in serum lipase or amylase
- Onset of abdominal pain within \<=48h before admission
- APACHE II \>= 8
- Evidence of \>= 1 predictor of severe pancreatitis:
- Haematocrit \>44% (male) or \>40% (female), respectively
- Blood glucose \> 125 mg/dl;
- CRP \>= 10 mg/dl;
- Age \> 55 years;
- Leukocytes \>= 16 G/L
- GOT \> 250 U/L;
- LDH \> 350 U/L
- Calcium \< 2,0 mmol/L
- CK \> upper normal range
- Balthazar-score(CT classification) Grade C-E
- Any organ failure
Exclusion
- Pregnancy
- NYHA \>II
- Pre-existing disease with life expectancy \< 3 months
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2020
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00894907
Start Date
August 1 2009
End Date
May 30 2020
Last Update
October 8 2020
Active Locations (1)
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1
2nd Medical Department; Klinikum Rechts der Isar
Munich, Germany, D-81675