NCT04966780

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

3.2 years

First QC Date

July 8, 2021

Last Update Submit

July 19, 2021

Conditions

Refeeding SyndromeAcute Abdomen

Keywords

refeeding syndromeacute abdominal disease

Outcome Measures

Primary Outcomes (1)

  • sodium balance

    correlation between sodium balance and occurrence of the refeeding syndrome

    7 days

Secondary Outcomes (3)

  • plasma phosphate

    7 days

  • urinary excretion of phosphate

    7 days

  • phosphate balance

    7 days

Interventions

acute abdominal surgeryPROCEDURE

Acute surgery for acute abdominal disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev University Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Refeeding SyndromeAbdomen, Acute

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic DiseasesAbdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • jens R Andersen

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Primary Investigator

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 19, 2021

Study Start

April 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)