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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00894907
First received: May 6, 2009
Last updated: October 7, 2013
Last verified: October 2013

May 6, 2009
October 7, 2013
August 2009
April 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00894907 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis
EAGLE: Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis: A Randomised Multi-centre Study

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.

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)

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Acute Pancreatitis
  • 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)

  • 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

  • Experimental: PiCCO-group
    Insertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids according to PiCCO-parameter-guided algorithm
    Intervention: Other: PiCCO-parameter-guided volume resuscitation
  • 2
    Control: Haemodynamic management without ITBI and ELWI using any other haemodynamic monitoring tool, with the exception of the PiCCO-system.
    Intervention: Other: Control-group
Huber W, Umgelter A, Reindl W, Franzen M, Schmidt C, von Delius S, Geisler F, Eckel F, Fritsch R, Siveke J, Henschel B, Schmid RM. Volume assessment in patients with necrotizing pancreatitis: a comparison of intrathoracic blood volume index, central venous pressure, and hematocrit, and their correlation to cardiac index and extravascular lung water index. Crit Care Med. 2008 Aug;36(8):2348-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
October 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Wolfgang Huber, MD ++49-89-4140-2265 Wolfgang.Huber@lrz.tum.de
Germany
 
NCT00894907
DFG: HU 1707/2-1
Yes
Technische Universität München
Technische Universität München
Not Provided
Not Provided
Technische Universität München
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP