Carbon Monoxide-based Rebreathing Method and Bioimpedance in Hemodialysis Patients

NCT04645121 | Completed

• 1 other identifier: H-20031445
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a case-control study with the primary aim of objectifying the volume status of patients receiving hemodialysis. Volume status will be assessed at dry weight and evaluated by a carbon monoxide rebreathing method, that measures blood volume, and bioimpedance that measures total body water. Case-control subjects will be matched on gender, age and weight. Secondary aims are to evaluate the carbon monoxide rebreathing method. Blood volumes obtained by the carbon monoxide rebreathing method will be correlated to blood volumes obtained by radioactive labelling of erythrocytes and albumin. In addition, it will be investigated whether hemoglobin is a valid marker of anemia in patients receiving hemodialysis by measuring the erythrocyte volume and the hemoglobin mass by the carbon monoxide rebreathing method and correlating this to the hemoglobin concentration measured before and after dialysis.

Conditions

Hemodialysis Complication; Volume Overload

Outcome Measures

Primary Outcomes (1)

• Blood volume by carbon monoxide rebreathing method

  Blood volume measured by carbon monoxide rebreathing method in ml/kg

  Day 1

Secondary Outcomes (14)

• Erythrocyte volume by carbon monoxide rebreathing method

  Day 1

• Plasma volume by carbon monoxide rebreathing method

  Day 1

• Blood volume by Nadler's formula

  Day 1

• Erythrocyte volume by Nadler's formula

  Day 1

• Plasma volume by Nadler's formula

  Day 1

Study Arms (2)

Hemodialysis group

Subjects receiving maintenance hemodialysis for at least three months

Device: Carbon Monoxide-based Rebreathing; Device: Bioimpedance; Radiation: Radioactive labelling of erythrocytes and albumin

Case group

Healthy subjects with eGFR above 60 ml/min/1.73m2

Device: Carbon Monoxide-based Rebreathing; Device: Bioimpedance; Radiation: Radioactive labelling of erythrocytes and albumin

Interventions

Carbon Monoxide-based Rebreathing DEVICE

6 minutes Carbon Monoxide-based Rebreathing that estimate blood volume, plasma volume and erythrocyte volume.

Case group; Hemodialysis group

Bioimpedance DEVICE

Measures total volume, intra and extracellular volume.

Case group; Hemodialysis group

Radioactive labelling of erythrocytes and albumin RADIATION

Measure blood volume, plasma volume and erythrocyte volume.

Case group; Hemodialysis group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total number of participants: 50 divided in two Groups: * 25 subjects receiving hemodialysis * 25 subjects with eGFR above 60 ml/min/1.73m2 The patients are recruited from the department of Nephrology at Rigshospitalet and Herlev Hospital.

You may qualify if:

• Man/woman aged 18-90 years
• Hemodialysis treatment for a minimum of 3 months
• BMI 18.5-50 kg/m2
• Man / woman aged 18-90 years
• Renal function with eGFR above 60ml / min and urine albumin-creatinine ratio below 300mg/g
• BMI: 18.5-50 kg / m2 Control group:

You may not qualify if:

• Pregnant or breastfeeding
• Hybrid dialysis (both hemodialysis and peritoneal dialysis simultaneously)
• Chronic obstructive pulmonary disease, asthma or interstitial pulmonary fibrosis
• Pulmonary embolism within 6 months
• Lung cancer or previous lung surgery.
• Pregnant or breastfeeding
• Known heart failure with Left ventricular ejection fraction ˂ 45%
• Liver failure (Child Pugh Score A, B or C)
• Chronic obstructive pulmonary disease, asthma or interstitial pulmonary fibrosis - Pulmonary embolism within 6 months
• Lung cancer or previous lung surgery. Active cancer
• HbA1c over 60mmol / mol
• Edema (except mild lower leg edema)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Herlev Hospital: collaborator

Study Sites (2)

Herlev Hospital

Copenhagen, 2100, Denmark

Location

Rigshospitalet, Department of Nephrology

København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Edema

Interventions

Albumins

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 27, 2020
• Study Start: November 25, 2020
• Primary Completion: May 20, 2022
• Study Completion: June 1, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

DK (2)