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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04966780
Other study ID # RLS in surgery
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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