Refeeding Like Syndrome in Acute Disease (RLS)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Abdomen; Refeeding Syndrome
• Intervention / Treatment: Procedure: acute abdominal surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sodium balance	correlation between sodium balance and occurrence of the refeeding syndrome	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma phosphate	correlation between sodium balance and change in plasma phosphate	7 days
urinary excretion of phosphate	correletion between sodium balance and urinary excretion of phosphate	7 days
phosphate balance	correlation between decline in plasma phosphate and urinary excretion of phosphate	7 days

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: refeeding syndrome; acute abdominal disease
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Signs and Symptoms, Digestive; Nutrition Disorders; Malnutrition; Abdominal Pain; Syndrome; Abdomen, Acute; Refeeding Syndrome
• Other Study ID Numbers: RLS in surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No