This study has been transitioned to CTIS with ID 2023-505220-57-03 check the CTIS register for the current data. The PLANCTON trial will investigate the effect of early intravenous OM-3 FAs on new onset organ failure and mortality in patients with…
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints will be evaluated after the 180 days study period. The primary
endpoint is a composite endpoint of new onset of organ failure (organ failure
not present at randomization) and mortality.
Secondary outcome
Secondary endpoints are individual components of the composite endpoint, severe
complications (([infected] pancreas necrosis, sepsis, pneumonia or
cholangitis), quality of life, costs effectiveness, number of (surgical,
endoscopic or radiologic) interventions, length of hospital and ICU stay.
Background summary
Acute pancreatitis (AP) is the most common gastrointestinal disorder requiring
acute hospitalization. About 20% of all patients will develop severe acute
pancreatitis (SAP) marked by a pro-inflammatory response and characterized by
massive release of cytokines, which can cause the systemic inflammatory
response syndrome (SIRS). SIRS increases the risk on (multi) organ failure and
contributes to a mortality up to 30%.
Intravenous omega-3 fatty acids (OM-3 FAs) induce the production of
anti-inflammatory cytokines and hereby ameliorate the inflammatory response. We
hypothesize that the anti-inflammatory function of OM-3 FAs could attenuate
SIRS and decrease the severity of SAP resulting in less (severe) organ failure
and ultimately a lower mortality. The clinical implications of this mechanism
is shown in a recent meta-analysis describing reduced mortality by the use of
OM-3 FAs in 4 randomized trials in patients with acute pancreatitis. However,
the evidence was of low quality and a large multicenter trial on OM-3 FAs in
predicted SAP is currently lacking. This could provide definitive proof for the
beneficial effect of OM-3 FAs in acute pancreatitis.
Study objective
This study has been transitioned to CTIS with ID 2023-505220-57-03 check the CTIS register for the current data.
The PLANCTON trial will investigate the effect of early intravenous OM-3 FAs on
new onset organ failure and mortality in patients with predicted SAP.
Study design
A multicenter randomized controlled trial
Intervention
Intravenous administration of a lipid emulsion (0.2g/kg/day) with OM-3 FAs,
started within 24hrs of diagnosis of predicted SAP and within 72hrs after onset
of symptoms of AP, for a total of 7 days.
Study burden and risks
The burden for participants in this study is limited. The risk of OM-3 FAs
administration is estimated to be negligible because (serious) adverse events
were not described in 14 randomized controlled trials in 551 patients (9 trials
in 322 patients with sepsis and 5 trials in 229 patients with acute
pancreatitis). Additionally, the known side effects of OM-3 FAs are rare (e.g.
lipid overload syndrome and prolonged bleeding time) or of relative limited
clinical importance (i.e. the taste of fish). The parenteral administration of
OM-3 FAs and questionnaires can be marked as a (small) burden in addition to
standard medical care. The benefit for (future) patients treated with OM-3 FAs
could be substantial with a reduction in new onset organ failure and mortality.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
• Predicted severe acute pancreatitis
• >=18 years old
• First episode of acute pancreatitis
• <24 hours after diagnosis of acute pancreatitis
• <72 hours after onset of symptoms of acute pancreatitis
• Able to read and/or understand the study procedures
• Able to give informed consent (or their legal representatives)
Exclusion criteria
• Intake of any OM-3 FAs-, krill and/or algae supplements in the week prior to
complaints
• Participation in another intervention study for AP
• Organ failure on admission (Modified Marshall score >2)
• Recurrent pancreatitis
• Chronic pancreatitis
o Defined by the MANNHEIM criteria53
• Known allergy to fish oil, seafood, soja or egg products
• History or existing hyperlipidemia (laboratory proven triglycerides > 10.0
mmol/l)
• History of (severe) liver failure
• Impaired lipid metabolism may lead to accumulation of fatty acids in the
blood, increasing risk of adverse events.
o Based on coagulation Factor V level or INR > 3
(without anti-coagulation by vitamine K)
• Ketoacidosis
• Acute thrombo-embolic disease
• Pregnancy or lactation
• Recent (< 6 months) myocardial infarction or strokeKnown coagulations
disorders
(e.g. Factor V Leiden, thrombocytopenia, etc.)
• Pancreatitis due to a (suspected) periampullary/ampullary or bile duct
malignancy
• Other known or suspected malignancy that may interfere with the outcome(s)
and/or execution of the PLANCTON trial
• Post ERCP-pancreatitis due to a (suspected) malignancy
• Patient is classified as moribund or expected to die within 24hours
o The intervention will not be able to affect this patient and is therefore
useless to expose these patients.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-505220-57-03 |
| EudraCT | EUCTR2022-000474-26-NL |
| CCMO | NL80570.091.22 |
| Other | Nummer volgt, ingediend bij ISRTCN |