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

March 6, 2024 updated by: Urban Fläring
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Pediatric Perioperative Medicine and Intensive Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children with suspected acute appendicitis

Description

Inclusion Criteria:

  • Children with suspected acute appendicitis

Exclusion Criteria:

  • Chronic metabolic disease
  • Endocrinological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Possible predictive variables will only be obtained at one occation on the day of admission to the emergency department.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Diagnostic values of interest are only obtained at one occasion on admission to the emergency department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urban Fläring

Collaborators

Odense University Hospital
Charite University, Berlin, Germany
Oslo University Hospital
Red Cross War Memorial Childrens Hospital

Investigators

  • Principal Investigator: Urban Fläring, Ass Prof, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K 2021-2319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is likely that we will share data on request when the study is published,

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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