- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00786591
Study of New Biological Markers for Prediction of Severe Acute Pancreatitis
27 december 2012 uppdaterad av: Medicine, National University Hospital, Singapore
Clinical Evaluation of Novel Biological Markers for the Prediction of Severe Acute Pancreatitis
Acute pancreatitis refers to inflammation of the pancreas and is associated with sudden onset of severe abdominal pain, often accompanied by transient systemic manifestations, including fever.
In the majority of cases, the inflammatory process is self limiting and patient recovers uneventfully; however, in about 20% to 30% of the cases, a protracted clinical course ensues and the disease may progress to a severe necrotizing form, often triggering a systemic inflammatory response syndrome during which time, acute respiratory distress syndrome, renal failure, shock, and disseminated intravascular coagulation may occur.
In the worst sequelae, multiple organ dysfunctions may follow and death supervene.
The clinical outcome of patients suffering from severe acute pancreatitis depends to a great extent on the early diagnosis and prediction of severity and timely therapeutic intervention to prevent local and systemic complications.
However, the course of the disease is often difficult to predict from the outset.
Currently, there is still no single clinical or laboratory test that can be considered the "gold standard" for diagnosis and/or assessment of severity of acute pancreatitis.
For a disease that may progress rapidly without apparent sign, the ideal marker for the prediction of disease severity in a patient would be one that is measurable rapidly and easily, besides being able to fulfill all the other criteria required of a good biological marker.
To identify such a potential marker for acute pancreatitis requires understanding of the pathophysiological process underlying the rapid progression of a fulminant course of the disease.
Although much remains to be elucidated, recent studies in animals have suggested that inflammatory mediators substance P and hydrogen sulfide may play critical roles.
This study will evaluate if inflammatory mediators substance P and hydrogen sulfide are upregulated early on in the disease process, and if the levels of their elevation predict disease severity.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
75
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Singapore, Singapore, 119074
- National University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients with clinical presentation suggestive of acute pancreatitis
Beskrivning
Inclusion Criteria:
The patient should fulfill all of the following criteria:
- The subject should be at least 18 years of age.
- Clinical features compatible with acute pancreatitis.
- First symptoms of acute pancreatitis not more than 72 hours before enrolment.
- Serum amylase level above 480 U/dl (normal 60-160 U/dl or 2-hour urinary amylase greater than 1120 U (normal 280 U).
- Serum lipase levels greater than 2 U (normal < 1 U).
- Patient has signed consent form regarding participation in the study.
Exclusion Criteria:
The patient should not present any of the following criteria:
- Symptoms of acute pancreatitis present for more than 72 hours
- Clinical evidence of sepsis or other inflammatory diseases.
- Clinical evidence of disorders/disease known to affect endogenous regulation of substance P, e.g. asthma, immune-complex-mediated lung injury, arthritis.
- Age under 18 years
- Pregnancy
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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Acute Pancreatitis Patients
Patients presenting with clinical features compatible with acute pancreatitis
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Control
Preoperative patients going for elective cholecystectomy
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Levels of substance P and hydrogen sulfide in blood measured 6-hourly over a time course of 3 days
Tidsram: On admission to hospital, blood sampling will be done every 6 hours for 3 days
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On admission to hospital, blood sampling will be done every 6 hours for 3 days
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Disease severity index derived from: (i) Ranson score; (ii) Acute Physiology and Chronic Health Evaluation (APACHE) II scores; (iv) Glasgow and (v) Multi-Organ System Failure (MOSF) Score
Tidsram: Within 3 days of hospital admission
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Within 3 days of hospital admission
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Tamizhselvi R, Moore PK, Bhatia M. Hydrogen sulfide acts as a mediator of inflammation in acute pancreatitis: in vitro studies using isolated mouse pancreatic acinar cells. J Cell Mol Med. 2007 Mar-Apr;11(2):315-26. doi: 10.1111/j.1582-4934.2007.00024.x.
- Bhatia M, Zhi L, Zhang H, Ng SW, Moore PK. Role of substance P in hydrogen sulfide-induced pulmonary inflammation in mice. Am J Physiol Lung Cell Mol Physiol. 2006 Nov;291(5):L896-904. doi: 10.1152/ajplung.00053.2006. Epub 2006 Jun 23.
- Hegde A, Bhatia M. Neurogenic inflammation in acute pancreatitis. JOP. 2005 Sep 10;6(5):417-21.
- Lau HY, Wong FL, Bhatia M. A key role of neurokinin 1 receptors in acute pancreatitis and associated lung injury. Biochem Biophys Res Commun. 2005 Feb 11;327(2):509-15. doi: 10.1016/j.bbrc.2004.12.030.
- Grady EF, Yoshimi SK, Maa J, Valeroso D, Vartanian RK, Rahim S, Kim EH, Gerard C, Gerard N, Bunnett NW, Kirkwood KS. Substance P mediates inflammatory oedema in acute pancreatitis via activation of the neurokinin-1 receptor in rats and mice. Br J Pharmacol. 2000 Jun;130(3):505-12. doi: 10.1038/sj.bjp.0703343.
- Bhatia M, Saluja AK, Hofbauer B, Frossard JL, Lee HS, Castagliuolo I, Wang CC, Gerard N, Pothoulakis C, Steer ML. Role of substance P and the neurokinin 1 receptor in acute pancreatitis and pancreatitis-associated lung injury. Proc Natl Acad Sci U S A. 1998 Apr 14;95(8):4760-5. doi: 10.1073/pnas.95.8.4760.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2006
Primärt slutförande (Faktisk)
1 juli 2009
Avslutad studie (Faktisk)
1 juli 2009
Studieregistreringsdatum
Först inskickad
4 november 2008
Först inskickad som uppfyllde QC-kriterierna
4 november 2008
Första postat (Uppskatta)
6 november 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
31 december 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 december 2012
Senast verifierad
1 december 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D/05/194
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .