Estimation of safe post-operative fluid therapy in childre

Not Applicable

• Conditions: Emergency intervention for treatment of acute appendicitis in children and adolescents; Surgery

• Registration Number: ISRCTN43896775
• Lead Sponsor: Karolinska University Hospital (Sweden)

Brief Summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21729308 2019 results in https://doi.org/10.1038/s41390-019-0353-4 (added 09/07/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-17
• Study Completion: 2012-11-01
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Male and female children and adolescents aged between 1 and 14 years old whose post-operative p-Na+ are within the normal range (local reference range: 135 ? 147 mmol/L)
2. Children and adolescents undergoing emergency intervention for treatment of acute appendicitis either as an open or laparoscopic procedure will be considered to be potentially eligible
To qualify for randomisation, the participants are required to have a complicated appendicitis, i.e. gangrenous or perforated, either with generalised or localised peritonitis of such a degree that the surgeon considers oral feeding unsuitable for at least 24 hours following the surgery. Consequently, the randomisation will be performed post-operatively and on the basis of intra-operative findings.

We infer that in our study population, the prescription of parenteral fluid therapy for the immediate 24 hours post-operative period might be justified and that by delaying oral fluid therapy intake, in any particular case, will do no harm to the patient.

Exclusion Criteria

1. Any clinical condition, such as renal disease, acute or chronic lung inflammation, pituitary or hypothalamic disease and adrenal insufficiency that eventually can lead to electrolyte and water imbalance
2. Any patient whose p-Na+ is < 130 mmol/L after the initiation of parenteral maintenance fluid therapy, will be withdrawn from the study and treated accordingly at the discretion of the anaesthesiologist responsible for the patient?s care

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate whether the post-operative prescription of either hypotonic (0.23% and 0.40% sodium chloride) or near-isotonic (0.81% sodium chloride) fluid therapy given at low maintenance rate in otherwise healthy children with normal post-operative p-Na+ are equally effective in maintaining p-Na+ within the normal range 24 h postoperatively

Secondary Outcome Measures

Name	Time	Method
To determine water and electrolyte-balance during the administration of the investigational parenteral maintenance fluids as well as to investigate known regulatory hormones involved in the homeostatic control of water balance. We will also seek to determine how frequently p-Na+ should be monitored during the 24 h post-operative period.