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Completed

NCT Number: NCT02602808

Study of Peripheral Blood Non-coding RNAs as Diagnosis and Prognosis Biomarker for Acute Pancreatitis

It is important to identify patients with acute pancreatitis who are at risk for developing persistent organ failure early in the course of disease. The investigators evaluated whether peripheral blood non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), could serve as a good marker for detection of acute pancreatitis with persistent organ failure at early phase.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Linyi People's Hospital, Linyi, Shandong, China

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About this study

Acute pancreatitis is a sudden inflammation of the pancreas. It can have severe complications and high mortality despite treatment. While mild cases are often successfully treated with conservative measures, such as fasting and aggressive intravenous fluid rehydration, severe cases may require admission to the intensive care unit or even surgery to deal with complications of the disease process. The diagnosis of severe acute pancreatitis at an early phase remain a major challenge for clinicians.

Therefore, many biologic markers have been studied in an effort to improve the diagnostic rate and determine the severity of acute pancreatitis but with disappointing results. Non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), have recently been validated to stably exist in peripheral blood. Several publications showed that it may serve as potential markers for various diseases, including cancer and inflammation. Our current study evaluated whether and which kind of non-coding RNAs could serve as good markers for severe acute pancreatitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who was diagnosed acute pancreatitis
  • Male or female
  • 18 Years and older
  • written informed consent

Exclusion criteria

  • Symptoms of acute pancreatitis present for more than 72 hours
  • Age under 18 years
  • Pregnancy
  • patients unable to consent

Treatment and study plan

Primary outcomes

  1. The level of non-coding RNAs in peripheral blood

    Time frame: At admission

    RNA quantification after extraction using RT-PCR

Secondary outcomes

  1. serum urea nitrogen

    Time frame: At admission

    serum urea nitrogen quantification

  2. serum creatinine

    Time frame: At admission

    serum creatinine quantification

  3. APACHE II score at admission

    Time frame: At admission

    APACHE II score determined by Temperature, MAP, heart rate, respiratory rate, Pao2, arterial pH, HCO3, sodium, potassium, creatinine, hematocrit, WBC, Glasgow Coma Score, age, chronic health points

  4. BISAP score at admission

    Time frame: At admission

    BISAP socre determined by BUN (>25 mg/dL), impaired mental status (Glasgow Coma Score <15), SIRS (≥2), age (>60 y), pleural effusion

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Acronym: NCRNAP

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2015
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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