Integrated Strategies to Prevent Intradialytic Hypotension (The DialHypot Study)

NCT03949088 | Unknown

• 1 other identifier: DialHypot
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is aimed at comparing different strategies of UF profiling, dialysate sodium individualization and sodium profiling (even combining one with the other) and at evaluating the effectiveness of a new UF profile which has an ascending/descending shape. The goal of the study is to provide better dialysis tolerance and lower rates of intradialytic hypotensive events by the application of this UF profile design in combination with a neutral sodium balance.

Conditions

Hypotension During Dialysis; Dialysis Hypotension

Keywords

Intradialytic hypotension (IDH); Ultrafiltration (UF) profiling; Sodium (Na) profiling; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Occurrence of intradialytic hypotensive episodes (number of episodes within every HD session and time interval from HD start)

  Hypotensive events and symptoms (headache, cramps, nausea and vomiting) will be recorded and analyzed as both number of occurrences and time of occurrence from the beginning of the HD session. IDH will be defined as follows: * "symptomatic IDH": decrease in SBP ≥ 20 mmHg or in MAP ≥ 10 mmHg associated with symptoms (KDIGO definition) * "asymptomatic IDH": drop in BP (SBP ≥ 20 mmHg or MAP ≥ 10 mmHg) within a 20 minutes interval, regardless of symptoms * for patients whose SBP is \< 100 mmHg at the beginning of treatment, the investigators will consider as IDH any decrease of SBP ≥ 10%

  Within each dialysis session from the time of enrolment to the end of each study phase (9-11 weeks)

Secondary Outcomes (2)

• Achievement of UF

  Within each dialysis session from the time of enrolment to the end of each study phase (9-11 weeks)

• Dialysis dose

  Within each dialysis session from the time of enrolment to the end of each study phase (9-11 weeks)

Study Arms (3)

Linear descending UF profile

EXPERIMENTAL

2-step descending Na profile, linear descending UF profile 3 weeks (9 sessions)

Other: UF and Na profiling

Run-in & washout phases

EXPERIMENTAL

constant Na concentration, constant UF rate 3 weeks (6+3 sessions)

Other: UF and Na profiling

Ascending/descending UF profile

EXPERIMENTAL

2-step descending Na profile, ascending/descending UF profile 3 weeks (9 sessions)

Other: UF and Na profiling

Interventions

UF and Na profiling OTHER

Modulation of UF and dialysate sodium

Ascending/descending UF profile; Linear descending UF profile; Run-in & washout phases

Eligibility Criteria

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

You may qualify if:

• written informed consent
• age ≥ 18 years
• thrice weekly HD regimen for more than 6 months
• "hypotension-prone patients": ≥ 3 episodes of IDH in the month preceding the run-in phase of the study

You may not qualify if:

• IDWG \< 1.4% of dry weight (corresponding to \< 1 kg in a 70-kg person)
• twice weekly HD regimen
• residual daily urine output \> 300 mL
• active acute disease or hospitalization in the 8 weeks preceding the run-in phase

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

University of Parma - UO Nefrologia AOU

Parma, Italy

Location

Related Publications (1)

• Peyronel F, Parenti E, Fenaroli P, Benigno GD, Rossi GM, Maggiore U, Fiaccadori E. Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients. BMJ Open. 2020 Jul 8;10(7):e036893. doi: 10.1136/bmjopen-2020-036893.

  PMID: 32641335 DERIVED

Central Study Contacts

Enrico Fiaccadori, Prof.

CONTACT

+390521703336; enrico.faccadori@unipr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 14, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)