NCT04662242

Brief Summary

Selenium is an important trace element for human for its multiple roles such as the antioxidant activity. Previous evidences showed that critically ill patients may benefit from selenium supplement but the dose and results are controversial. Patients after operations for acute abdomen usually suffer from sepsis and stress. The aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see the impact on prognosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2022

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

November 29, 2020

Last Update Submit

February 8, 2023

Conditions

Critical IllnessSelenium DeficiencyTrace Element DeficiencyAcute AbdomenSepsis

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    mortality rate in 30 days

    30 day

Secondary Outcomes (4)

  • hospital length

    1 year

  • ventilator length

    1 year

  • complication rate

    30 days

  • organ failure rate

    30 days

Study Arms (4)

low serum selenium with selenium supplement

EXPERIMENTAL

Patients having low serum selenium with selenium supplement given

Drug: Selenium Supplement

low serum selenium with placebo supplement

PLACEBO COMPARATOR

Patients having low serum selenium with placebo given

Drug: normal saline

non-low serum selenium with selenium supplement

ACTIVE COMPARATOR

Patients having normal serum selenium with selenium supplement given

Drug: Selenium Supplement

non-low serum selenium with placebo supplement

PLACEBO COMPARATOR

Patients having normal serum selenium with placebo given

Drug: normal saline

Interventions

Selenium SupplementDRUG

Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days

Also known as: Zelnite
low serum selenium with selenium supplementnon-low serum selenium with selenium supplement
normal salineDRUG

normal saline 100ml iv infusion for 7 days

low serum selenium with placebo supplementnon-low serum selenium with placebo supplement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intensive care unit (ICU) patients receiving abdominal surgeries for acute abdomen
  • within 48 hours post-operatively
  • stay in ICU for more than 48 hours
  • meets sepsis criteria of Sepsis-3 (2016)

You may not qualify if:

  • liver cirrhosis Child-Pugh score B or C
  • breastfeeding or pregnancy
  • allergy yo selenium
  • vegetative status or irreversible diseases with life-expectancy fewer than 28 days
  • End-stage renal disease under dialysis
  • Human immunodeficiency virus infection
  • neutropenia not due to sepsis (granulocyte \< 1000/mm3)
  • Heart failure (New York Heart Association class III-IV) or recent myocardial infarction (within 6 weeks)
  • post cardiopulmonary cerebral resuscitation within 4 weeks
  • taking immunosuppressants
  • receiving anti-cancer therapy
  • signed do not resuscitation
  • joined other clinical research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

  • Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.

    PMID: 30348463BACKGROUND

  • Allingstrup M, Afshari A. Selenium supplementation for critically ill adults. Cochrane Database Syst Rev. 2015 Jul 27;2015(7):CD003703. doi: 10.1002/14651858.CD003703.pub3.

    PMID: 26214143BACKGROUND

MeSH Terms

Conditions

Critical IllnessAbdomen, AcuteSepsis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAbdominal PainPainNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, DigestiveInfectionsSystemic Inflammatory Response SyndromeInflammation

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yu-Tung Wu, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 10, 2020

Study Start

December 1, 2020

Primary Completion

October 31, 2022

Study Completion

November 16, 2022

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)