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Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis

NCT00894907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-01
Primary Completion
2020-02-01
Completion
2020-05-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894907 on ClinicalTrials.gov