Effects of Treatments for Anemia and Iron Deficiency on the Electrolyte Balance in Lung Transplant Recipients: A Special Focus on Hypophosphatemia

October 26, 2023 updated by: University of Zurich
The aim of this study is to generate evidence regarding hypophosphatemia after iron infusion in lung transplant recipients in context of anemia and/or iron deficiency.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, 8091
        • University Hospital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

lung transplant recipient

Description

Inclusion Criteria:

  • lung transplant recipient
  • treated at the University Hospital Zurich between 2015 until 2022

Exclusion Criteria:

  • Denied general consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of serum phosphate level
Time Frame: Baseline and up to 90 days after iron infusion
Change of serum phosphate level before and after iron infusion
Baseline and up to 90 days after iron infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of urin phosphate level
Time Frame: Baseline and up to 90 days after iron infusion
Change of urin phosphate level before and after iron infusion
Baseline and up to 90 days after iron infusion
Change of hemoglobin
Time Frame: Baseline and up to 90 days after iron infusion
Change of hemoglobin level before and after iron infusion
Baseline and up to 90 days after iron infusion
Change of mean corpuscular volume (MCV)
Time Frame: Baseline and up to 90 days after iron infusion
Changes of serum MCV level before and after iron infusion
Baseline and up to 90 days after iron infusion
Change of mean corpuscular hemoglobin (MCH)
Time Frame: Baseline and up to 90 days after iron infusion
Change of serum MCH level before and after iron infusion
Baseline and up to 90 days after iron infusion
Change of serum magnesium
Time Frame: Baseline and up to 90 days after iron infusion
Change of serum magnesium level before and after iron infusion
Baseline and up to 90 days after iron infusion
Change of serum and urin calcium
Time Frame: Baseline and up to 90 days after iron infusion
Change of serum and urin calcium level before and after iron infusion
Baseline and up to 90 days after iron infusion
Change of serum albumin
Time Frame: Baseline and up to 90 days after iron infusion
Change of serum albumin level before and after iron infusion
Baseline and up to 90 days after iron infusion
Complications after iron infusion
Time Frame: 2015-2022
Number of patients with complications due to hypophosphatemia after iron infusion (Hospitalization, hypoxia, fracture due to hypophosphatemia)
2015-2022
Predictors
Time Frame: baseline and up to 90 days after iron infusion
Analysis of possible predictors for the decrease of serum phosphate levels after iron infusion
baseline and up to 90 days after iron infusion
Therapeutic management
Time Frame: 2015 to 2022
Descriptive analysis of therapeutic management of hypophosphatemia after iron infusion
2015 to 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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