Temperature and Bicarbonate: Hemodynamic Effects During Dialysis

NCT05052151 | Completed

• 1 other identifier: 23-06-21
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To elucidate the role of dialysate temperature and bicarbonate on hemodynamic parameters, plasma pH and electrolytes that potentially mediate this effect, the investigators wish to conduct a single-blinded, randomized, controlled, crossover study, specifically examining the effects of

• A fixed low temperature dialysate of 35°C compared to a fixed dialysate temperature of 37°C.
• A low dialysate bicarbonate concentration of 30 mmol/L compared to a high dialysate bicarbonate concentration of 38 mmol/L.

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

• Blood pressure (BP)

  SBP (mmHg), Mean BP (mmHg) and Ortostatic BP (mmHg)

  4 weeks

Secondary Outcomes (11)

• Intradialytic cardiac output

  4 weeks

• Intradialytic total peripheral resistance

  4 weeks

• Intradialytic stroke volume

  4 weeks

• Intradialytic heart rate

  4 weeks

• Intradialytic central blood volume

  4 weeks

Study Arms (4)

Low temperature

ACTIVE COMPARATOR

Dialysate temperature

Other: Low dialysate temperature

High temperature

ACTIVE COMPARATOR

Dialysate temperature

Other: High dialysate temperature

Low bicarbonate

ACTIVE COMPARATOR

Dialysate bicarbonate concentration

Other: Low dialysate bicarbonate concentration

High bicarbonate

ACTIVE COMPARATOR

Dialysate bicarbonate concentration

Other: High dialysate bicarbonate concentration

Interventions

Low dialysate temperature OTHER

35°C

Low temperature

High dialysate temperature OTHER

37°C

High temperature

Low dialysate bicarbonate concentration OTHER

30 mmol/L

Low bicarbonate

High dialysate bicarbonate concentration OTHER

38 mmol/L

High bicarbonate

Eligibility Criteria

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

You may qualify if:

• Regular dialysis (HD or HDF) therapy for \>3 months
• Age \>18 years
• Stable and functional arteriovenous (AV)-fistula
• Able to achieve a dialysis blood flow \> 250 mL
• Able to stand up for a minimum of 10 min
• Able to undergo a 4 hour dialysis session without eating, drinking or sleeping
• Proven cabable of cumulative ultrafiltration of 2% of end-dialytic weight (EDW)
• Able to give informed consent to participation in the study
• Hematocrit \>30%
• BMI \>18 and \<35

You may not qualify if:

• Central venous catheter for HD or HDF
• Recirculation in AV-fistula
• Acute myocardial infarction within 3 months
• Atrial fibrillation
• Active malignant or infectious diseases
• Cerebrovascular incident within 3 months
• Pregnancy
• Alcohol or drug abuse
• History of interruptions during HD or untimely termination of HD treatment

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Dialysis Clinic at Department of Renal Medicine, Aarhus University Hospital and affiliated dialysis clinics in Randers and Horsens

Aarhus, Region Midt, 8200, Denmark

Location

Related Publications (35)

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Study Officials

• Niels H Buus, Professor

  Department of Renal Medicine, Aarhus University Hospital

  STUDY CHAIR

• Jens D Jensen, MD, PhD

  Department of Renal Medicine, Aarhus University Hospital

  STUDY CHAIR

• Ina H Jørgensen, Student

  Department of Renal Medicine, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Jonas SK Jensen, Student

  Department of Renal Medicine, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Christian D Peters, MD, PhD

  Department of Renal Medicine, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Temperature or bicarbonate settings will not be revealed to participants during the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a single-blinded, randomized, controlled, crossover study with each participant being his or her own control. Participants will be blinded to the intervention and the order of the interventions will be random. Participants will be randomized using bloc randomization. We will create two blocs with 8 participants in each. The four dialysis sessions will be conducted on the same weekday each week, which results in a 1-week wash-out period with standard dialysis treatment between interventions.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 22, 2021
• Study Start: August 25, 2021
• Primary Completion: December 20, 2021
• Study Completion: January 3, 2022
• Last Updated: May 18, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)