NCT03840629

Brief Summary

Retrospective audit of adult patients who underwent major surgery in our institution, and biochemical outcomes including hyponatremia, in relation to the maintenance fluid tonicity administered peri-operatively.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
659

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 13, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2015

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

February 11, 2019

Last Update Submit

February 11, 2019

Conditions

HyponatremiaSurgeryFluid and Electrolyte Imbalance

Outcome Measures

Primary Outcomes (1)

  • Hyponatraemia

    Hyponatraemia post surgery

    48 to 72 hrs post surgery

Secondary Outcomes (2)

  • Hypokalemia

    48 to 72 hrs post surgery

  • Acute kidney injury

    48 to 72 hrs post surgery

Study Arms (2)

Hypotonic fluid maintenance

exclusive administration of 0.33% saline mixed with potassium and dextrose 5%

Other: No study intervention.

Isotonic fluid maintenance

exclusive administration of 0.9% saline

Other: No study intervention.

Interventions

No study intervention.OTHER
Hypotonic fluid maintenanceIsotonic fluid maintenance

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult surgical patients

You may qualify if:

  • exclusive administration of either fluid types.

You may not qualify if:

  • Patients who received saline boluses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

November 13, 2014

Primary Completion

June 12, 2015

Study Completion

November 12, 2015

Last Updated

February 15, 2019

Record last verified: 2019-02