NCT04806789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
451

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

March 12, 2021

Last Update Submit

November 25, 2024

Conditions

Acute AppendicitisChildren, Only

Keywords

Acute appendicitisChildrenPlasma Sodium

Outcome Measures

Primary Outcomes (1)

  • Plasma sodium concentration as a predictor for perforated acute appendicitis.

    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 Outcomes (1)

  • Plasma sodium concentration adding precision to the diagnostic performance of "the Appendicitis Inflammatory Response (AIR) score".

    Diagnostic values of interest are only obtained at one occasion on admission to the emergency department

Study Arms (1)

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

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with suspected acute appendicitis

You may qualify if:

  • Children with suspected acute appendicitis

You may not qualify if:

  • Chronic metabolic disease
  • Endocrinological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Perioperative Medicine and Intensive Care

Stockholm, 17176, Sweden

Location

Related Publications (4)

  • Andersson RE, Petzold MG. Nonsurgical treatment of appendiceal abscess or phlegmon: a systematic review and meta-analysis. Ann Surg. 2007 Nov;246(5):741-8. doi: 10.1097/SLA.0b013e31811f3f9f.

    PMID: 17968164BACKGROUND

  • Lindestam U, Almstrom M, Jacks J, Malmquist P, Lonnqvist PA, Jensen BL, Carlstrom M, Krmar RT, Svensson JF, Norberg A, Flaring U. Low Plasma Sodium Concentration Predicts Perforated Acute Appendicitis in Children: A Prospective Diagnostic Accuracy Study. Eur J Pediatr Surg. 2020 Aug;30(4):350-356. doi: 10.1055/s-0039-1687870. Epub 2019 Apr 25.

    PMID: 31022754BACKGROUND

  • Pogorelic Z, Luksic B, Nincevic S, Luksic B, Polasek O. Hyponatremia as a predictor of perforated acute appendicitis in pediatric population: A prospective study. J Pediatr Surg. 2021 Oct;56(10):1816-1821. doi: 10.1016/j.jpedsurg.2020.09.066. Epub 2020 Oct 8.

    PMID: 33153722BACKGROUND

  • Scott AJ, Mason SE, Arunakirinathan M, Reissis Y, Kinross JM, Smith JJ. Risk stratification by the Appendicitis Inflammatory Response score to guide decision-making in patients with suspected appendicitis. Br J Surg. 2015 Apr;102(5):563-72. doi: 10.1002/bjs.9773. Epub 2015 Mar 2.

    PMID: 25727811BACKGROUND

Related Links

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Urban Fläring, Ass Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor. Senior Consultant.

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 19, 2021

Study Start

June 1, 2021

Primary Completion

November 25, 2024

Study Completion

November 25, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

SE(1)