Fluid Currents During Hemodialysis

NCT06394843 | Not Yet Recruiting

• 1 other identifier: MVVH
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

During dialysis, three objectives are achieved. 1. Blood is cleansed from waste products. 2. Excess water is removed. 3. Electrolytes are regulated. These processes occur simultaneously but vary from patient to patient depending on their specific needs. Some patients still produce urine, but of poor quality. Others have no residual urine production at all and require removal of fluid from both blood and tissues. Hypotension may occur during dialysis, related to intravascular hypovolemia and inadequate fluid reinfusion, which is common during ultrafiltration exceeding 400 ml/h. The amount of fluid removed is influenced by fluid recruitment from tissues. This mainly occurs in two different ways: osmotic recruitment across capillary membranes from the perivascular space or via lymphatic reflow. The proportions are not fully understood. When fluid is recruited from the perivascular space, the influx of albumin and immunoglobulins is unlikely. However, these should accompany lymph to the blood if lymphatic flow is increased. The content of albumin and immunoglobulins differs between lymph and plasma. Thus, the proportions of fluid recruitment from tissues should be calculable using mass balance calculations based on ultrafiltrate, colloid osmotic pressure, hemoglobin, albumin, and immunoglobulin concentrations. The rate and proportions of fluid reinfusion into the bloodstream are not fully understood. Therefore, in this study, the aim is to monitor fluid reinfusion and its proportions of lymph/osmotic recruitment into the bloodstream.

Conditions

Patients Undergoing Hemodialysis

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Proportion of fluid recruited via endothelial wall vs lymph

  Recruitment of fluid from the interstitium calculated from fluid removal and hemoglobin changes. Proportion of recruited fluid via lymph or via capillary/venulae walls based on fluid recruitment and changes in plasma albumin and immunoglobulins G and M

  8 hours

Secondary Outcomes (3)

• Weight

  8 hours

• Blood pressure

  8 hours

• Bioimpedance

  8 hours

Study Arms (2)

<500 ml Ultrafiltration

Patients undergoing hemodialysis with less than 500 ml ultrafiltration

Other: Ultrafiltration

>2000 ml Ultrafiltration

Patients undergoing hemodialysis with than 2000 ml ultrafiltration

Other: Ultrafiltration

Interventions

Ultrafiltration OTHER

Patients are selected depending on need of ultrafiltration

<500 ml Ultrafiltration; >2000 ml Ultrafiltration

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing hemodialysis regularly at the dialysis department at Vrinnevisjukhuset in Norrköping are screened if they are expected to meet the inclusion criteria for the study. Those who meet the inclusion criteria and have no exclusion criteria are asked to participate.

You may qualify if:

• Patients undergoing hemodialysis (\<500 ml or \>2000 ml ultrafiltration)

You may not qualify if:

• Patients who may be affected by blood sampling, i.e., have low hemoglobin concentration independent of dilution before dialysis (Hb 85 g/L).
• Patients who drink large amounts of water during regular dialysis (\> 2 glasses, approximately 0.5 L).

Sponsors & Collaborators

• Joachim Zdolsek: lead
• Region Östergötland: collaborator

Study Sites (1)

Vrinnevi Hospital

Norrköping, Östergötland County, 60379, Sweden

Location

Related Publications (1)

• Zdolsek JH, Zdolsek M, Hahn RG. Recruitment of efferent lymph during infusion of 20 % albumin. Microvasc Res. 2023 Jul;148:104539. doi: 10.1016/j.mvr.2023.104539. Epub 2023 May 6.

  PMID: 37156370 BACKGROUND

MeSH Terms

Interventions

Ultrafiltration

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Officials

• Jonathan Bodare, MD

  Region Oestergoetland

  PRINCIPAL INVESTIGATOR

• Erik Golsäter, MD

  Region Oestergoetland

  PRINCIPAL INVESTIGATOR

• Fredrik Sundelin, MD

  Region Oestergoetland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joachim Zdolsek, MD

CONTACT

+46101031821; joachim.zdolsek@regionostergotland.se

Robert Svensson, MD

CONTACT

+46101042305; robert.svensson@regionostergotland.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor, Principal investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 1, 2024
• Study Start: May 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Approximately 6 to 12 months after completion of the study.

Locations

SE (1)