Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— EAGLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894907
• Other study ID #: DFG: HU 1707/2-1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2009
• Est. completion date: May 30, 2020

Study information

• Verified date: October 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 30, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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)
• 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

Locations

Country	Name	City	State
Germany	2nd Medical Department; Klinikum Rechts der Isar	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 venou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)		4 days after admission to the ICU
Secondary	Mortality		ICU-, 28-days- and in hospital mortality
Secondary	APACHE-II-Score		4d; 7d; 28d
Secondary	Number of ICU-days		Admission to transfer or death
Secondary	Percentage of organ failure within each group		Time of ICU-stay