Refeeding Like Syndrome in Acute Disease

Acute Abdomen Clinical Trial

— RLS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04966780
• Other study ID #: RLS in surgery
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Abdomen
• Refeeding Syndrome
• Syndrome

Intervention

Procedure:
• acute abdominal surgery
Acute surgery for acute abdominal disease

Locations

Country	Name	City	State
Denmark	Herlev University Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Jens Rikardt Andersen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sodium balance	correlation between sodium balance and occurrence of the refeeding syndrome	7 days
Secondary	plasma phosphate	correlation between sodium balance and change in plasma phosphate	7 days
Secondary	urinary excretion of phosphate	correletion between sodium balance and urinary excretion of phosphate	7 days
Secondary	phosphate balance	correlation between decline in plasma phosphate and urinary excretion of phosphate	7 days