Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis

NCT00894907 | Completed DMC

• 1 other identifier: DFG: HU 1707/2-1
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

Severe pancreatitis; acute pancreatitis; haemodynamic monitoring; PiCCO

Outcome Measures

Primary Outcomes (1)

• Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)

  4 days after admission to the ICU

Secondary Outcomes (4)

• Mortality

  ICU-, 28-days- and in hospital mortality

• APACHE-II-Score

  4d; 7d; 28d

• Number of ICU-days

  Admission to transfer or death

• Percentage of organ failure within each group

  Time of ICU-stay

Study Arms (2)

PiCCO-group

EXPERIMENTAL

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

Other: PiCCO-parameter-guided volume resuscitation

2

OTHER

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

Other: Control-group

Interventions

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)

PiCCO-group

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

2nd Medical Department; Klinikum Rechts der Isar

Munich, D-81675, Germany

Location

Related 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 venous pressure, and hematocrit, and their correlation to cardiac index and extravascular lung water index. Crit Care Med. 2008 Aug;36(8):2348-54. doi: 10.1097/CCM.0b013e3181809928.

  PMID: 18596637 RESULT

MeSH Terms

Conditions

Pancreatitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2020
• Study Completion: May 30, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

DE (1)