Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis

Not Applicable

Completed

• Conditions: Acute Pancreatitis
• Interventions: Other: PiCCO-parameter-guided volume resuscitation; Other: Control-group

• Registration Number: NCT00894907
• Lead Sponsor: Technical University of Munich

Brief 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.

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 Timeline

• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-06
• Study First Posted: 2009-05-07
• Study Start: 2009-08-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-05-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PiCCO-group	PiCCO-parameter-guided volume resuscitation	Insertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids according to PiCCO-parameter-guided algorithm
2	Control-group	Control: Haemodynamic management without ITBI and ELWI using any other haemodynamic monitoring tool, with the exception of the PiCCO-system.

Primary Outcome Measures

Name	Time	Method
Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)	4 days after admission to the ICU

Secondary Outcome Measures

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

Trial Locations

Locations (1)

2nd Medical Department; Klinikum Rechts der Isar; 🇩🇪 Munich, Germany