Acute Pancreatitis Targets (APT) Study

NCT04570852 | Completed DMC

• 1 other identifier: APT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The severity of acute pancreatitis varies considerably from minor symptoms to multi-organ failure. The pathophysiological mechanisms associated with these individual differences in severity are largely unknown. Acute pancreatitis is therefore classified based on clinical characteristics and routine blood samples. Information about pathophysiology and molecular subtypes of acute pancreatitis is needed to develop specific biomarkers and identify new drug targets. The investigators therefore plan to undertake an explorative study, which includes state-of-the-art biochemical assessment of patients with acute pancreatitis including multi-OMICS focusing on transcriptomics and proteomics.

Conditions

Pancreatitis, Acute

Outcome Measures

Primary Outcomes (1)

• Number of Participants with severe pancreatitis

  Development og severe pancreatitis according to standard definitions

  90 days

Study Arms (1)

Intensive monitoring of patients

EXPERIMENTAL

State of the art biochemical assessment of patients with acute pancreatitis including multi-OMICS focusing on transcriptomics and proteomics.

Other: LiDCO

Interventions

LiDCO OTHER

We plan to elucidate the pathophysiology and molecular subtypes of acute pancreatitis in order to develop specific biomarkers and identify new drug targets. The evaluation will include an analysis of the impact of obesity and the metabolic profile during the disease course of acute pancreatitis. Supportive treatments will be registered including an assessment of the fluid balance based on the fluid intake and loss and weight. Bioimpedance will be assessed at admission/day1, day 2, day 3,

Also known as: Bioimpedance, Ommics, Rutine blood samples, TEQ

Intensive monitoring of patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age \>18 years) with acute pancreatitis according to the revised Atlanta criteria;12
• Informed consent;
• Known time of debut of symptoms.

You may not qualify if:

• Chronic pancreatitis;
• Pregnancy;
• Known malignant disease;

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Gastroenheden, Hvidovre Hospital

Hvidovre, Capital, 2650, Denmark

Location

Related Publications (6)

• Xiao AY, Tan ML, Wu LM, Asrani VM, Windsor JA, Yadav D, Petrov MS. Global incidence and mortality of pancreatic diseases: a systematic review, meta-analysis, and meta-regression of population-based cohort studies. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):45-55. doi: 10.1016/S2468-1253(16)30004-8. Epub 2016 Jun 28.

  PMID: 28404111 BACKGROUND

• Landspatientregisteret. Datatræk på "Akut pankreatitis". Tilgået 6 juni 2019. Tilgængelig via: esundhed.dk.

  BACKGROUND

• Novovic S, Andersen AM, Ersboll AK, Nielsen OH, Jorgensen LN, Hansen MB. Proinflammatory cytokines in alcohol or gallstone induced acute pancreatitis. A prospective study. JOP. 2009 May 18;10(3):256-62.

  PMID: 19454816 BACKGROUND

• Mofidi R, Duff MD, Wigmore SJ, Madhavan KK, Garden OJ, Parks RW. Association between early systemic inflammatory response, severity of multiorgan dysfunction and death in acute pancreatitis. Br J Surg. 2006 Jun;93(6):738-44. doi: 10.1002/bjs.5290.

  PMID: 16671062 BACKGROUND

• van Santvoort HC, Bakker OJ, Bollen TL, Besselink MG, Ahmed Ali U, Schrijver AM, Boermeester MA, van Goor H, Dejong CH, van Eijck CH, van Ramshorst B, Schaapherder AF, van der Harst E, Hofker S, Nieuwenhuijs VB, Brink MA, Kruyt PM, Manusama ER, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, Cuesta MA, Wahab PJ, Gooszen HG; Dutch Pancreatitis Study Group. A conservative and minimally invasive approach to necrotizing pancreatitis improves outcome. Gastroenterology. 2011 Oct;141(4):1254-63. doi: 10.1053/j.gastro.2011.06.073. Epub 2011 Jul 8.

  PMID: 21741922 BACKGROUND

• Johnson CD, Abu-Hilal M. Persistent organ failure during the first week as a marker of fatal outcome in acute pancreatitis. Gut. 2004 Sep;53(9):1340-4. doi: 10.1136/gut.2004.039883.

  PMID: 15306596 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, PhD

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 30, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

DK (1)