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

Technical University of Munich

Status: Completed

Conditions: Acute Pancreatitis

Treatments: Other: PiCCO-parameter-guided volume resuscitation; Other: Control-group

Study type: Interventional

Funder types: Other

Identifiers

NCT00894907

DFG: HU 1707/2-1

Details and patient eligibility

About

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.

Full 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)

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

PiCCO-group

Experimental group

Description:

Insertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids according to PiCCO-parameter-guided algorithm

Treatment:

Other: PiCCO-parameter-guided volume resuscitation

2

Other group

Description:

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

Treatment:

Other: Control-group