Acute PancreatitisEAGLENCT00894907
Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis
A study testing PiCCO-parameter-guided volume resuscitation in people with Acute Pancreatitis, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- PiCCO-parameter-guided volume resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2009to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 17Show fewer
- 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
Who cannot join
- Pregnancy
- NYHA >II
- Pre-existing disease with life expectancy < 3 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
2nd Medical Department; Klinikum Rechts der Isar
Munich, D-81675
About this study
Official title: EAGLE: Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis: A Randomised Multi-centre Study
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.
Read the 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)
- Conditions
- Acute Pancreatitis
- Being tested
- PiCCO-parameter-guided volume resuscitation, Control-group
- Keywords
- Severe pancreatitis, acute pancreatitis, haemodynamic monitoring, PiCCO
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCCO-parameter-guided volume resuscitationOther
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-groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| PiCCO-group | Experimental | Insertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids according to PiCCO-parameter-guided algorithm Receives: 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. Receives: Other: Control-group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)
Measured: 4 days after admission to the ICU
Secondary outcomes (4)
Mortality
Measured: ICU-, 28-days- and in hospital mortality
APACHE-II-Score
Measured: 4d; 7d; 28d
Number of ICU-days
Measured: Admission to transfer or death
Percentage of organ failure within each group
Measured: Time of ICU-stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study start1 Aug 2009
- Primary completion1 Feb 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894907
- Sponsor's protocol ID
- DFG: HU 1707/2-1
- Acronym
- EAGLE
- Status last verified
- Oct 2020
- First submitted
- 6 May 2009
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18596637
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EAGLE: Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis: A Randomised Multi-centre Study
- ClinicalTrials.gov ID
- NCT00894907
- Acronym / sponsor ID
- EAGLE / DFG: HU 1707/2-1
- Conditions
- Acute Pancreatitis
- Keywords
- Severe pancreatitis, acute pancreatitis, haemodynamic monitoring, PiCCO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Aug 2009 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PiCCO-group | Experimental | Other: PiCCO-parameter-guided volume resuscitationInsertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids according to PiCCO-parameter-guided algorithm |
| 2 | Other | Other: Control-groupControl: Haemodynamic management without ITBI and ELWI using any other haemodynamic monitoring tool, with the exception of the PiCCO-system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis of pancreatitis:
- Onset of abdominal pain within <=48h before admission
- APACHE II >= 8
- Evidence of >= 1 predictor of severe pancreatitis:
Key exclusion criteria (3 listed)
- Pregnancy
- NYHA >II
- Pre-existing disease with life expectancy < 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiCCO-parameter-guided volume resuscitationInsertion 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 | PiCCO-group |
| Control-groupHaemodynamic 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 | Other | 2 |
Primary outcome
Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)
Time frame: 4 days after admission to the ICU
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Results publication: PubMed 18596637Huber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PiCCO-parameter-guided volume resuscitation in people with Acute Pancreatitis, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU) (time frame: 4 days after admission to the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00894907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.