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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Technische Universität München.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00894907
First received: May 6, 2009
Last updated: June 29, 2015
Last verified: June 2015
  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
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:


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 ]

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

Estimated Enrollment: 190
Study Start Date: August 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Technische Universität München
ClinicalTrials.gov Identifier: NCT00894907     History of Changes
Other Study ID Numbers: DFG: HU 1707/2-1
Study First Received: May 6, 2009
Last Updated: June 29, 2015

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 July 19, 2017