NCT04564508

Brief Summary

The aim of the present study is to identify the prevalence and prognostic impact of sodium imbalance on sepsis and septic shock patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

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

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

September 21, 2020

Last Update Submit

January 11, 2021

Conditions

Sodium Disorder

Outcome Measures

Primary Outcomes (1)

  • Sodium level disorders in Sepsis

    Correlation between sodium level disorders in septic and septic shock patients and the outcome represented by ICU mortality and ICU length stay

    Baseline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Septic and septic shock patients admitted to the ICU to evaluate their sodium status

You may qualify if:

  • The diagnosis of sepsis and septic shock was made prior to the ICU admission. Sepsis and septic shock were defined according to the 3 definition using the Quick Sofa score of 2 or more
  • Sepsis : 2 or more of the SIRS criteria :
  • Temperature \>38 or \<36 c
  • Heart Rate \>90 beats/minute
  • Respiratory rate \>20 cycle /minute
  • wbc \>20,000 or \< 4,000 Plus the presumed existence of infection
  • Blood pressure can be normal Septic shock : the same as sepsis plus refractory hypotension
  • After bolus of 20- 40 ml/kg patient has one of the following :
  • SBP \>90 mm Hg
  • MAP \<65 mm Hg
  • Decrease of 40 mm Hg of base line hypernatremia \[Na+\]\> 145 mmol/L eunatremia \[135-145\]mmol/l hyponatremia \<135 mmol/L

You may not qualify if:

  • patients under the age of 18 years patients with a previous diagnosis of hyperaldosteronism patints diagnosed with Cushing syndrome, patients diagnosed with diabetes insipidus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Kareem Sherif, Resident doctor

CONTACT

01002447880kareemsherif14@gmail.com

Ahmed Mohamed Obeid Allah, Assistant professor

CONTACT

01007556396

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01