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

October 6, 2020 updated by: Technical University of Munich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, D-81675
        • 2nd Medical Department; Klinikum Rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)
Time Frame: 4 days after admission to the ICU
4 days after admission to the ICU

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2009

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 6, 2009

First Posted (Estimate)

May 7, 2009

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFG: HU 1707/2-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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