Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Temperature and Bicarbonate: Hemodynamic Effects During Dialysis (TURBO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05052151
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease on Dialysis Other: Low dialysate temperature Other: High dialysate temperature Other: Low dialysate bicarbonate concentration Other: High dialysate bicarbonate concentration Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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.

Masking: Single (Participant)
Masking Description: Temperature or bicarbonate settings will not be revealed to participants during the study.
Primary Purpose: Treatment
Official Title: Hemodynamic Effects of Low vs. High Dialysate Temperature or Bicarbonate Concentration in Chronic Hemodialysis Patients
Actual Study Start Date : August 25, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : January 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Low temperature
Dialysate temperature
Other: Low dialysate temperature
35°C

Active Comparator: High temperature
Dialysate temperature
Other: High dialysate temperature
37°C

Active Comparator: Low bicarbonate
Dialysate bicarbonate concentration
Other: Low dialysate bicarbonate concentration
30 mmol/L

Active Comparator: High bicarbonate
Dialysate bicarbonate concentration
Other: High dialysate bicarbonate concentration
38 mmol/L




Primary Outcome Measures :
  1. Blood pressure (BP) [ Time Frame: 4 weeks ]
    SBP (mmHg), Mean BP (mmHg) and Ortostatic BP (mmHg)


Secondary Outcome Measures :
  1. Intradialytic cardiac output [ Time Frame: 4 weeks ]
    CO (L/min)

  2. Intradialytic total peripheral resistance [ Time Frame: 4 weeks ]
    TPR (mmHg/(L/min))

  3. Intradialytic stroke volume [ Time Frame: 4 weeks ]
    SV (mL)

  4. Intradialytic heart rate [ Time Frame: 4 weeks ]
    HR (beats/min)

  5. Intradialytic central blood volume [ Time Frame: 4 weeks ]
    CBV (L)

  6. Intradialytic mean arterial blood pressure [ Time Frame: 4 weeks ]
    MAP (mmHg)

  7. Plasma calcium [ Time Frame: 4 weeks ]
    Calcium (mmol/L)

  8. Plasma potassium [ Time Frame: 4 weeks ]
    Potassium (mmol/L)

  9. Plasma magnesium [ Time Frame: 4 weeks ]
    Magnesium (mmol/L)

  10. Intradialytic hypotension (IDH) [ Time Frame: 4 weeks ]
    IDH frequency (number of events)

  11. Ortostatic hypotension (OH) [ Time Frame: 4 weeks ]
    OH frequency (number of events)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052151


Contacts
Layout table for location contacts
Contact: Christian D Peters, MD, PhD +45 40460343 cdp@clin.au.dk
Contact: Jens D Jensen, MD, PhD +45 61308617 jenjesen@rm.dk

Locations
Layout table for location information
Denmark
Dialysis Clinic at Department of Renal Medicine, Aarhus University Hospital and affiliated dialysis clinics in Randers and Horsens Recruiting
Aarhus, Region Midt, Denmark, 8200
Contact: Christian D Peters, MD, PhD         
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Study Chair: 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
Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by University of Aarhus:
Study Protocol  [PDF] June 23, 2021

Publications:

Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT05052151    
Other Study ID Numbers: 23-06-21
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions