Prediction of Risk of Hypotension in Hemodialysis

NCT03350308 | Completed

• 2 other identifiers: CHU-3632014-A01538-39
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.

Conditions

Chronical Kidney Disease; Hypotension; Residual Blood Volume; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Risk of PAS with symptom

  The primary outcome will be the risk of a decrease in PAS of more than 20 mmHg or a decrease in WFP of at least 10 mmHg associated with clinical symptomatology (vertigo, malaise, nausea or cramps)

  at 3 week

Secondary Outcomes (3)

• Risk of PAS with symptom without symptom

  at 3 week

• risk of reduction of PAS below 90 mmHg (with or without symptoms)

  at 3 week

• risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps

  at 3 week

Study Arms (1)

Patients with chronic end-stage renal failure

Other: hemodialysis

Interventions

hemodialysis OTHER

The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration

Patients with chronic end-stage renal failure

Eligibility Criteria

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

Study Population

Patients with chronic end-stage renal failure

You may qualify if:

• years old minimum patients
• Patients with chronic end-stage renal failure
• Patients treated with hemodialysis for at least 3 months, 3 times a week (duration of sessions 3 to 5 hours)
• Patients with at least 2 episodes of intradialytic hypotension in the last month
• Patients affiliated with or receiving social security benefits

You may not qualify if:

• Hemoglobin levels outside the limits of measurement (\<7 g/L or \>15g/L)
• Patients whose probable survival does not exceed 6 months
• Patients with progressive acute pathology
• Patient following another research protocol that may influence results
• Patients with psychiatric pathology or cognitive impairments that make them unable to give informed consent

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Fresenius Medical Care North America: collaborator
• Centre de dialyse AURA Plaisance: collaborator
• Pôle Santé République: collaborator
• Service de Néphrologie et Hémodialyse: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Hypotension

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Julien ANIORT

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 22, 2017
• Study Start: January 1, 2015
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

FR (1)