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Sodium concentration as a predictor for perforated appendicitis in children

Sodium concentration as a predictor for perforated appendicitis in children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000047392
Enrollment
80
Registered
2017-01-10
Start date
2016-06-06
Completion date
2017-07-04
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

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.

Sponsors

Urban Flaring
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
1 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

Previously healthy pediatric patients with suspected (ultrasound) appendicitis.

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026