An interventional study of PiCCO-parameter-guided volume resuscitation and Control-group in Acute Pancreatitis, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment
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.
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)
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's planned enrollment of 190 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of pancreatitis:
Evidence of >= 1 predictor of severe pancreatitis:
Exclusion Criteria:
Insertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids according to PiCCO-parameter-guided algorithm
Other: PiCCO-parameter-guided volume resuscitation
Control: Haemodynamic management without ITBI and ELWI using any other haemodynamic monitoring tool, with the exception of the PiCCO-system.
Other: Control-group
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)
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
Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)
Time frame: 4 days after admission to the ICU
Mortality
Time frame: ICU-, 28-days- and in hospital mortality
APACHE-II-Score
Time frame: 4d; 7d; 28d
Number of ICU-days
Time frame: Admission to transfer or death
Percentage of organ failure within each group
Time frame: Time of ICU-stay
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Technical University of Munich