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Plasma Sodium: a Predictor of Perforation in Acute Appendicitis. (The NAP-study)

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ClinicalTrials.gov Identifier: NCT04806789
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : September 2, 2021
Sponsor:
Collaborators:
Odense University Hospital
Charite University, Berlin, Germany
Red Cross War Memorial Childrens Hospital
Oslo University Hospital
Information provided by (Responsible Party):
Urban Fläring, Karolinska Institutet

Study Description
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Brief Summary:
This clinical prospective diagnostic accuracy study assesses plasma sodium concentration using blood gas analysis at the emergency department in children, age 1-15 years, with suspected acute appendicitis. The overall assumption is that using plasma sodium as a biomarker, a cut-off value of <136 mmol/L will differentiate perforated from non-perforated acute appendicitis. In addition, traditionally used clinical diagnostic variables as well as radiology used in the diagnosis of acute appendicitis will also be obtained. Histopathology will be used to define if the appendix is perforated or not.

Condition or disease
Acute Appendicitis Children, Only

Detailed Description:

Background: The historical dogma that acute appendicitis always progresses to gangrene and perforation has been rejected. In addition, there is evolving evidence that medical treatment of non-perforated acute appendicitis is safe. On the other hand, perforated acute appendicitis requires appendectomy [Andersson]. Therefore, it is important to differentiate perforation from non-perforation in order to enable proper treatment.

In a pilot-study in children with acute appendicitis (n=80), plasma sodium was shown to be an independent predictor differentiating between perforated and non-perforated acute appendicitis [Lindestam]. Using plasma sodium at a cut-off value of <136 mmol/L, the odds ratio of having a perforated acute appendicitis was 31.9 (95% CI, 6.3- 161.9) with an area under the receiver operating curve of 0.93. Sensitivity and specificity were 0.87 (95 % CI 0.60-0.98) and 0.83 (95 % CI 0.72-0.91). Similar results have later been shown by another research group [Pogorelic]. Possible mechanism for lower plasma sodium among patients with perforation is higher concentration of arginin-vasopressin, which has previously been shown [Lindestam].

Methods: Participants (n=450 in total) whereof 150 in Sweden, 150 in Republic of South Africa, 50 in Germany, 50 in Denmark and 50 in Norway will be included in the study. The patients/parents will be asked for participation in the study and included after decision of surgery has been made by the attendant surgeon. At this timepoint, (i) variables from clinical examination/history (presence of right iliac fossa pain, rebound tenderness, duration of symptoms, vomiting, temperature, gender, age, weight, (ii) blood sampling: blood gas (including plasma sodium), C-reactive protein, neutrophiles, White blood cell count (obtained at the emergency department) and (iii) radiology has been obtained. No intervention is planned. These variables will also be used to calculate the Appendicitis Inflammatory Responce (AIR) score [Scott]. Thereafter, plasma sodium concentration will be added and the score will be recalculated.

After surgery, histopathology will be used to determine if the appendix is perforated or not.

Study Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Sodium: a Predictor of Perforation in Acute Appendicitis. (The NAP-study)
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Groups and Cohorts
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Group/Cohort
Children with suspected acute appendicitis

Cohort: Children with suspected acute appendicitis. Clinical examination (including history of nausea, vomiting, temperature, information of rebound tenderness, right iliac fossa pain, duration of symptoms, gender and weight) and blood samples will be obtained at the emergency department (blood gas, C-reactive protein, neutrophiles and white blood cell count). Radiology (ultrasound and/or computed tomography) will be performed thereafter.

Outcome measures

Primary outcome measure: Plasma sodium. To investigate if plasma sodium is an independent predictor of perforation in children with acute appendicitis. In advance, five variables (Plasma sodium, C-reactive protein, symptom duration, age and temperature) will be included in the final multivariable analysis


Outcome Measures
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Primary Outcome Measures :
  1. Plasma sodium concentration as a predictor for perforated acute appendicitis. [ Time Frame: Possible predictive variables will only be obtained at one occation on the day of admission to the emergency department. ]
    Plasma sodium will be dichotomized at 136 mmol/L. Lower concentration are hypothesized to indicate perforated acute appendicitis.


Secondary Outcome Measures :
  1. Plasma sodium concentration adding precision to the diagnostic performance of "the Appendicitis Inflammatory Response (AIR) score". [ Time Frame: Diagnostic values of interest are only obtained at one occasion on admission to the emergency department ]
    This score uses anthropometric and laboratory values that will be obtained on admission to the emergency department. Adding plasma sodium to these values in regression analysis to increase possibility to predict perforated acute appendicitis.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with suspected acute appendicitis
Criteria

Inclusion Criteria:

  • Children with suspected acute appendicitis

Exclusion Criteria:

  • Chronic metabolic disease
  • Endocrinological disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806789


Contacts
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Contact: Urban Fläring, Ass Prof +46708763900 urban.flaring@ki.se

Locations
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Sweden
Pediatric Perioperative Medicine and Intensive Care Recruiting
Stockholm, Sweden, 17176
Contact: Urban Fläring, Ass Prof    +46708763900    urban.flaring@ki.se   
Sponsors and Collaborators
Urban Fläring
Odense University Hospital
Charite University, Berlin, Germany
Red Cross War Memorial Childrens Hospital
Oslo University Hospital
Investigators
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Principal Investigator: Urban Fläring, Ass Prof Karolinska Institutet
More Information
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Additional Information:
Scott  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Urban Fläring, Associate Professor. Senior Consultant., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04806789    
Other Study ID Numbers: K 2021-2319
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is likely that we will share data on request when the study is published,

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urban Fläring, Karolinska Institutet:
Acute appendicitis
Children
Plasma Sodium
Additional relevant MeSH terms:
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Appendicitis
Acute Disease
Intraabdominal Infections
Infections
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes