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Completed

NCT Number: NCT04966780

Refeeding Like Syndrome in Acute Disease

The refeeding syndrome has been reported without any evidence of prolopnged semistarvation, thus being different from the traditional disease.

The investigators wanted to investigate, if sodium infusions could be part of the explanation.

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Key information

Conditions

Refeeding Syndrome Abdomen, Acute Abdominal Pain Acute Abdomen Malnutrition Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev University Hospital

Herlev, 2730, Denmark

About this study

Background: Refeeding syndrome is conventionally connected to start of feeding after prolonged periods of semi-starvation and adaption. However, it is also described in acutely ill patients and in ICU patients without a history of adaption, but sometimes only defined as a drop in p-phosphate without clinical manifestations. The investigators hypothesize, that a positive sodium balance could induce the refeeding-like syndrome (RLS).

Method: Consecutive patients for acute, abdominal surgery were included and observed until discharge or up to seven days postoperatively with daily sodium and phosphate balance measurements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 yr
  • ready for acute surgery
  • able to understand and cooperate.

Exclusion criteria

  • pregnancy or breastfeeding
  • renal insufficiency (p-creatinine>400 micr mol/l)
  • re-operations
  • expected hospital stay < 24 hours.

Treatment and study plan

Acute abdominal surgery

Procedure

Acute surgery for acute abdominal disease

Primary outcomes

  1. sodium balance

    Time frame: 7 days

    correlation between sodium balance and occurrence of the refeeding syndrome

Secondary outcomes

  1. plasma phosphate

    Time frame: 7 days

    correlation between sodium balance and change in plasma phosphate

  2. urinary excretion of phosphate

    Time frame: 7 days

    correletion between sodium balance and urinary excretion of phosphate

  3. phosphate balance

    Time frame: 7 days

    correlation between decline in plasma phosphate and urinary excretion of phosphate

Sponsors and collaborators

Lead sponsor

Jens Rikardt Andersen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Dose-response Relation Between the Development of a Refeeding-like Syndrome and Sodium Balance in Patients Undergoing Acute Abdominal Surgery

Acronym: RLS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2021
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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