ULtrafiltration-Rate Induced CArdiac Strain (ULRICA) - Study

NCT06153888 | Recruiting

• 1 other identifier: Dnr 2022-03861-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients performing chronic hemodialysis (HD) retain more or less water between dialyses. The water is removed by ultrafiltration and usually during the cleansing of waste products - the HD. The length of HD is usually the same as the time of fluid removal while sometimes this may differ. There is no clear guideline. In previous research the investigator noted that the heart releases more NT-pro-BNP during HD in numerous of the patients. The present study aims to clarify if the speed of fluid removal during HD is a factor that may alter the release of cardiac markers during HD. If so the recommendations for the prescription of HD can be updated.

Conditions

Fluid Overload; Dialysis; Complications

Keywords

dialysis prescription

Outcome Measures

Primary Outcomes (1)

• Change in NT-pro-BNP (proBNP)

  The investigation focuses on the marker for cardiac strain pro-BNP (ng/L). Question: Does the heart get less release of markers for cardiac strain upon a slower speed of fluid removal.

  Per patient: two dialyses within 8 days; Study period:1 year

Secondary Outcomes (2)

• Change in troponin T

  Per patient: two dialyses within 8 days; Study period:1 year

• Adverse events

  Per patient: two dialyses within 8 days; Study period:1 year

Study Arms (2)

Standard hemodialysis prescription

ACTIVE COMPARATOR

Short dialysis time and higher ultrafiltration rate/hour dialysis (speed) is used

Procedure: Ultrafiltration rate

Modified hemodialysis prescription

EXPERIMENTAL

Prolonged dialysis time and less ultrafiltration rate/hour dialysis

Procedure: Ultrafiltration rate

Interventions

Ultrafiltration rate PROCEDURE

Fluid removal during HD will be linear. The time on HD for fluid removal is adjusted after a formula for interdialytic weight gain / removal time (see Goto et al 2023).

Modified hemodialysis prescription; Standard hemodialysis prescription

Eligibility Criteria

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

You may qualify if:

• Patients need to be able to understand the study information
• Patients need to be able to give consent.

You may not qualify if:

• Active systemic inflammatory state such as extensive malignancy or acute septic infection.
• Uncontrolled hyperphosphatemia decided by the local routine of the physician (due to somewhat decreased efficacy of the low flux filter to eliminate phosphate)

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Region Vasterbotten, Norrlands Universitetssjukhus, Dialysen

Umeå, SE90185, Sweden

RECRUITING

Related Publications (3)

• Schneditz D, Putz-Bankuti C, Ribitsch W, Schilcher G. Correction of plasma concentrations for effects of hemoconcentration or hemodilution. ASAIO J. 2012 Mar-Apr;58(2):160-2. doi: 10.1097/MAT.0b013e318243660f.

  PMID: 22370687 BACKGROUND

• Goto J, Forsberg U, Jonsson P, Matsuda K, Nilsson B, Nilsson Ekdahl K, Henein MY, Stegmayr BG. Interdialytic weight gain of less than 2.5% seems to limit cardiac damage during hemodialysis. Int J Artif Organs. 2021 Aug;44(8):539-550. doi: 10.1177/0391398820981385. Epub 2020 Dec 18.

  PMID: 33339470 RESULT

• Goto J, Ott M, Stegmayr B. Myocardial markers are highly altered by higher rates of fluid removal during hemodialysis. Hemodial Int. 2024 Jan;28(1):17-23. doi: 10.1111/hdi.13124. Epub 2023 Oct 24.

  PMID: 37875435 RESULT

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernd Stegmayr, MD, PhD

  Umea University, Umea, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernd Stegmayr, MD, PhD

CONTACT

+46706264533; bernd.stegmayr@umu.se

Michael Ott, MD, PhD

CONTACT

+46722224470; michael.ott@regionvasterbotten.se

Study Design

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

Model Details: crossover- such as the same patient performs 1) a standard hemodialysis and one week later 2) an experimental hemodialysis (change in ultrafiltration time)

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: December 1, 2023
• Study Start: March 20, 2023
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)