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Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis (EAGLE)

This study is currently recruiting participants.
Verified November 2012 by Technische Universität München
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00894907
First received: May 6, 2009
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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 mortality of up to 42% and frequently prolonged hospitalisation in the survivors. Despite a fulminant pathophysiology comparable to that of sepsis, the management of NP is still re-active, symptomatic and mainly based on paradigms with low grade evidence. In sepsis beneficial effects of early goal-directed fluid resuscitation resulting in reduced mortality have been clearly shown. With regard to these data and several studies of NP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission, early goal-directed fluid resuscitation has the potential of improving outcome also in NP. Therefore, it is the aim of this RCT to demonstrate beneficial effects of early goal-directed resuscitation using an algorithm based on modern haemodynamic parameters such as Intra-thoracic Blood Volume Index (ITBI), Extravascular Lung Water Index (ELWI) and Stroke Volume Variation (SVV) which can be easily and safely obtained due to recent progress in haemodynamic monitoring. The algorithm is aimed at maintaining adequate resuscitation (ITBI, SVV) as well as preventing pulmonary over-hydration (ELWI).The use of a similar algorithm in cardiac surgery patients resulted in a significant reduction in catecholamine use, lactate levels, duration of ventilation and ICU stay.


Condition Intervention
Acute Pancreatitis
 Other: PiCCO-parameter-guided volume resuscitation
Other: Control-group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EAGLE: Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis: A Randomised Multi-centre Study

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU) [ Time Frame: 4 days after admission to the ICU ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: ICU-, 28-days- and in hospital mortality ] [ Designated as safety issue: Yes ]
  • APACHE-II-Score [ Time Frame: 4d; 7d; 28d ] [ Designated as safety issue: Yes ]
  • Number of ICU-days [ Time Frame: Admission to transfer or death ] [ Designated as safety issue: Yes ]
  • Percentage of organ failure within each group [ Time Frame: Time of ICU-stay ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 190
Study Start Date: August 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PiCCO-group
Insertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids according to PiCCO-parameter-guided algorithm
 Other: PiCCO-parameter-guided volume resuscitation

Insertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids with the following goals:

ITBI: 850-1000 ml/sqm, if ELWI <=12*ml/kg; ITBI 750-850 ml/sqm, if ELWI >12*ml/kg and/or PaO2:FiO2 <200 (*ELWI<=12ml/kg, if MAP>65mmHg without catecholamines; ELWI<=14ml/kg, if catecholamines required for MAP>65mmHg); SVV<10% (only in controlled ventilation and sinus rhythm); MAP>65mmHg (MAP: Mean Arterial Pressure); IAPP >60mmHg (IAPP: Intra-abdominal Perfusion Pressure)
2
Control: Haemodynamic management without ITBI and ELWI using any other haemodynamic monitoring tool, with the exception of the PiCCO-system.
 Other: Control-group

Haemodynamic management without ITBI and ELWI using any other haemodynamic monitoring tool, with the exception of the PiCCO-system.

Main haemodynamic goals: CVP 8-12 mmHg; MAP >65mmHg;IAPP >60mmHg

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, if MAP>65mmHg without catecholamines <=14ml/kg, if catecholamines required for MAP>65mmHg SVV <10% (only in controlled ventilation and sinus rhythm) MAP >65mmHg (MAP: Mean Arterial Pressure) IAPP >60mmHg (IAPP: Intra-abdominal Perfusion Pressure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of pancreatitis:

    • Typical pain
    • Increase in serum lipase or amylase
  2. Onset of abdominal pain within <=48h before admission
  3. APACHE II >= 8

  4. 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 Criteria:

  1. Pregnancy
  2. NYHA >II
  3. Pre-existing disease with life expectancy < 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894907

Contacts
Contact: Wolfgang Huber, MD ++49-89-4140-2265 Wolfgang.Huber@lrz.tum.de

Locations
Germany
2nd Medical Department; Klinikum Rechts der Isar Recruiting
Munich, Germany, D-81675
Contact: Wolfgang Huber, MD     ++49-89-4140-2265     Wolfgang.Huber@lrz.tum.de    
Principal Investigator: Wolfgang Huber, MD            
Sub-Investigator: Sebastian Mair            
Sponsors and Collaborators
Technische Universität München
  More Information

Publications:

Responsible Party: PD Dr. med. Wolfgang Huber, 2nd Medical Department; Klinikum Rechts der Isar; Technical University of Munich
ClinicalTrials.gov Identifier: NCT00894907     History of Changes
Other Study ID Numbers: DFG: HU 1707/2-1
Study First Received: May 6, 2009
Last Updated: November 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
Severe pancreatitis
acute pancreatitis
haemodynamic monitoring
PiCCO

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013