Skip to main content
OpenTrials
Completed

NCT Number: NCT00894907

Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Medical Department; Klinikum Rechts der Isar

Munich, D-81675, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Pregnancy
  • NYHA >II
  • Pre-existing disease with life expectancy < 3 months

Treatment and study plan

PiCCO-parameter-guided volume resuscitation

Other

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)

Control-group

Other

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

Primary outcomes

  1. 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 outcomes

  1. Mortality

    Time frame: ICU-, 28-days- and in hospital mortality

  2. APACHE-II-Score

    Time frame: 4d; 7d; 28d

  3. Number of ICU-days

    Time frame: Admission to transfer or death

  4. Percentage of organ failure within each group

    Time frame: Time of ICU-stay

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

EAGLE: Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis: A Randomised Multi-centre Study

Acronym: EAGLE

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
May 7, 2009
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.