ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000047392

Ethics application status

Approved

Date submitted

1/12/2016

Date registered

10/01/2017

Date last updated

2/02/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Sodium concentration as a predictor for perforated appendicitis in children

Scientific title

Sodium concentration as a predictor for perforated appendicitis in children

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Nil known

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Perioperative hyponatremia in pediatric surgical patients.

Water balance disturbance in pediatric surgical patients

Stress induced catabolism in pediatric surgical patients

Appendicitis

Condition category

Condition code

Surgery

Other surgery

Metabolic and Endocrine

Other endocrine disorders

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

All patients with an expected appendicitis is asked for participation in the study. Also, parents are asked. The study period extends from inclusion to the end of the surgical procedure. Blood samples (3 ml) for the determination of blood gas (including sodium concentration), urea, osmolality, ketones, creatinine, cortisol, ADH, aldosterone and renin are taken at the emergency department by a specialist nurse (in addition to the routine samples) and at the end of surgery by a anaesthetic nurse. After induction of anesthesia a blood sample of blood gas and ketones (0,4 ml) is also taken. In addition, urine production is noted and samples are taken for the determination of osmolality, the concentrations of sodium, potassium, creatinine and urea. All the patients are fasted as part of the clinical routines. The volume of all given intravenous fluids during the study period are recorded. Hence the patients are given the normal clinical routines, the interventions are extra blood sampling and sampling from urine. The given fluid and the and the urine output are also recorded.

Intervention code [1]

Not applicable

Comparator / control treatment

The primary aim is to investigate if serum sodium concentration is significantly lower in pediatric patients with perforated appendicitis as compared to pediatric patients not having perforation (gangrenous phlegmonous appendicitis). These two groups are compared. There are no conventional control group.

Control group

Active

Outcomes

Primary outcome [1]

Serum sodium concentration compared between the two groups, perforated appendicitis vs non-perforated (gangrenous phlegmonous appendicitis).

Timepoint [1]

At admission at the emergency department.

Primary outcome [2]

Specificity and sensitivity of serum sodium at admission as a predictor of perforated vs non-perforated, established by review of surgical records.

Timepoint [2]

At admission at the emergency department.

Secondary outcome [1]

Rate of hyponatremia, defined as serum sodium concentration < 136 mmol/L.

Timepoint [1]

From admission to the end of the surgical procedure.

Secondary outcome [2]

Correlation between ADH and sodium concentrations, assessed by serum assay.

Timepoint [2]

From admission to the emergency department to the end of the surgical procedure.

Secondary outcome [3]

Correlation between serum ketone concentration and severity of appendicitis (by 5-point numerical rating scale designed for this study).

Timepoint [3]

From admission to the emergency department to the end of the surgical procedure.

Secondary outcome [4]

Correlation of occurance of hyponatraemia (defined as serum sodium concentration <136 mmol/L) with sodium administration (as recorded in the medical records).

Timepoint [4]

From admission to the emergency department to end of the surgical procedure.

Secondary outcome [5]

Correlation between aldosterone and sodium concentrations, assessed by serum assay.

Timepoint [5]

From admission to the emergency department to end of the surgical procedure.

Secondary outcome [6]

Correlation between renin and sodium concentrations, assessed by serum assay.

Timepoint [6]

From admission to the emergency department to end of the surgical procedure.

Secondary outcome [7]

Correlation of occurance of hyponatraemia (defined as serum sodium concentration <136 mmol/L) with free water administration (as recorded in the medical records).

Timepoint [7]

From admission to the emergency department to end of the surgical procedure.

Secondary outcome [8]

Correlation between serum ketone concentration and the amount of given glucose

Timepoint [8]

From admission to the emergency department to end of the surgical procedure.

Eligibility

Key inclusion criteria

Previously healthy pediatric patients with suspected (ultrasound) appendicitis.

Minimum age

1 Years

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Hyponatremia < 136 mmol/L, significant chronic disease, severe hypovolemia requiring bolus fluid at the emergency department.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Normality will be assessed using the D’Agostino & Pearson omnibus normality test. Data normally distributed will be given as means and standard deviation (SD). Non-parametric data values are given as median and interquartile range (IQR). Student’s t-test, Wilson matched pair test, One-way ANOVA followed by Tukey’s post hoc test, were used when applicable using GraphPad Prism 5 (GraphPad Software, Inc.7825 Fay Avenue, Suite 230 La Jolla, CA 92037 USA).
Regarding the number of patients needed to be included to answer the primary question, it was not possible to calculate power when the study was designed due to lack of knowledge of the standard deviation in sodium concentration at admission in patients with and without perforated appendicitis. Our assumption of a SD of at least 4 was uncertain and would require 200 patients. Therefore, we analysed the difference and SD after 40 patients. The obtained information gave a SD of 2,5. Our assumption is still a significant difference of 2 mmol/L. From empirical data, approximately 15 % of the patients will have a perforated appendix and 85 % will not. The power calculation showed that including 80 patients (65 and 15 in each group) with an assumed difference of 2 mmol/L and an SD of 2.5 mol/L will give a power of 80 %.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

6/06/2016

Date of last participant enrolment

Anticipated

31/05/2017

Actual

4/07/2017

Date of last data collection

Anticipated

31/05/2017

Actual

4/07/2017

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Sweden

State/province [1]

Stockholm

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Karolinska University Hospital

Address [1]

Department of Pediatric Perioperative Medicine
Karolinska University Hospital
17176
Stockholm

Country [1]

Sweden

Primary sponsor type

Individual

Name

Urban Flaring

Address

Department of Pediatric Perioperative Medicine
Karolinska University Hospital
17176 Stockholm

Country

Sweden

Secondary sponsor category [1]

Individual

Name [1]

Per-Arne Lonnqvist

Address [1]

Department of Pediatric Perioperative Medicine
Karolinska University Hospital
17176 Stockholm

Country [1]

Sweden

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee of Stockholm

Ethics committee address [1]

Regionala etikprovningsnamnden i Stockholm
Wiederstromska huset
Tomtebodavagen 18 A, plan 3. 
17165 Solna

Ethics committee country [1]

Sweden

Date submitted for ethics approval [1]

12/05/2016

Approval date [1]

23/05/2016

Ethics approval number [1]

Dnr: 2016/181-31/2

Summary

Brief summary

There are mainly two purposes with this study. The primary aim is to elucidate if pediatric patients with perforated appendicitis have lower sodium concentration at admission to the emergency department and if low sodium concentration can serve as a predictor for the likelihood of a patient having appendix perforation.  This is of clinical importance since appendicitis with a perforation needs to be diagnosed urgently, not delaying the surgical procedure so that complications can be avoided. 

The main secondary question is to characterise sodium concentration from admission to the end of surgery in patients with appendicitis. Hyponatremia is often seen in acutely ill children, including surgical patients, and can be severe if  maintenance fluids with a low sodium content is given. Severe hyponatremia can result in encephalopathy and even death. To a large extent this is caused by an increased production of the antidiuretic hormone arginine-vasopressin (AVP or ADH). However, when fluids for maintenance and/or rehydration that contain almost the same concentration of sodium as in normal serum are used, hyponatremia may occur. This may be explained by an expansion of the extra cellular volume resulting in a suppression of the hormones, renin and  aldosterone. Also an increased secretion of atrial natriuretic or brain natriuretic factor can contribute to the development of hyponatremia in a hypervolemic state.  The study will clarify the incidence of hyponatremia and to what extent the amount of  sodium in the given fluid and the amount of fluid given contribute to hyponatremia and the incidence of syndrome of inappropriate antidiuresis (SIAD). This will be achieved by recording all fluid going into the patient and out of the patient by urine production. Also the hormones involved in the sodium turn-over (ADH, renin, aldosterone and cortisol) will be measured as well as osmolality in serum and urine. In urine also the concentration of creatinine, urea, 
The results of this study may give sufficient information for the design of future interventional studies where the aim will be to elucidate optimal amount of sodium in the maintenance/rehydration fluid and the optimal amount of fluid. 

Appendicitis in children common world wide and by studying these patients, it may be possible to generalise to other diagnosis requiring acute surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Urban Flaring

Address

Department of Pediatric Perioperative Medicine
Karolinska University Hospital
17176 Stockholm

Country

Sweden

Phone

+46708763900

Fax

urban.flaring@ki.se

Contact person for public queries

Name

Urban Flaring

Address

Department of Pediatric Perioperative Medicine
Karolinska University Hospital
17176 Stockholm

Country

Sweden

Phone

+46 708763900

Fax

urban.flaring@ki.se

Contact person for scientific queries

Name

Urban Flaring

Address

Department of Pediatric Perioperative Medicine
Karolinska University Hospital
17176 Stockholm

Country

Sweden

Phone

+46708763900

Fax

urban.flaring@ki.se

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Low Plasma Sodium Concentration Predicts Perforated Acute Appendicitis in Children: A Prospective Diagnostic Accuracy Study.	2020	https://dx.doi.org/10.1055/s-0039-1687870

N.B. These documents automatically identified may not have been verified by the study sponsor.

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