The evaluation of the influence of the use of total blood volume measurement during dialysis on the incidence of intradialytic hypotension associated events

The evaluation of the influence of the use of total blood volume measurement during dialysis on the incidence of intradialytic hypotension associated events - Total blood volume measurement in hemodialysis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55297

Enrollment

120

Registered

2020-04-14

Start date

2020-07-09

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry weight target weight in hemodialysis

Interventions

During two mid-week hemodialysis sessions 240 millilitres isotonic ultrapure dialysate will be infused, which will be ultrafiltrated during the same hemodialysis session. Since this is exactly the s

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: hemodialysis patients of three dialysis locations of the Haga Hospital (Zoetermeer, The Hague Leyweg and The Hague Sportlaan). - Chronic hemodialysis patients in whom initiation of treatment predates inclusion in the study by >= 3 months. - Hemodialysis scheme three times weekly for four hours (Monday - Wednesday - Friday or Tuesday - Thursday - Saturday) - Age >18 years. - Signed informed consent must be obtained prior to any study specific procedures.

Exclusion criteria

Exclusion criteria: • Clinically relevant fistula dysfunction resulting in spKtV 1x intradialytic hypotension associated adverse event /week according to treating physician • Severe liver failure with or without presence of ascites • More than three hemodialysis sessions per week • Single needle treatment • Central venous access • Residual diuresis • Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
The primary objective is to investigate the effectivity of total blood volume measurement and the identification of a critical threshold to predict and prevent intra-dialytic hypotension and/or associated symptoms (IHAAE).It will be investigated wheter adjustment of target weight, based on the critical threshold of total blood volume, results in a decline of IHAAE frequency.IHAAE is defined as a systolic blood pressure	—

Measure

Time frame

The primary objective is to investigate the effectivity of total blood volume measurement and the identification of a critical threshold to predict and prevent intra-dialytic hypotension and/or associated symptoms (IHAAE).It will be investigated wheter adjustment of target weight, based on the critical threshold of total blood volume, results in a decline of IHAAE frequency.IHAAE is defined as a systolic blood pressure

—

Secondary

Measure	Time frame
1. To investigate the incidence of asymptomatic hypotension in the intervention group compared the control group. 2. To investigate the incidence hypotension-associated symptoms without hypotension in the intervention group compared to the control group. 3. To explore the distribution of normalized total blood volume and relative blood volume in stable subjects and subjects with IHAAE. 4. To calculate the sensitivity, specificity, positive predictive value and negative predictive value of the previously defined critical threshold for the normalized total blood volume of 65 ml/kg and the receiver operator characteristics for this threshold. 5. To compare measured total blood volume with calculated blood volume using Nadler*s formula	—

Measure

Time frame

1. To investigate the incidence of asymptomatic hypotension in the intervention group compared the control group. 2. To investigate the incidence hypotension-associated symptoms without hypotension in the intervention group compared to the control group. 3. To explore the distribution of normalized total blood volume and relative blood volume in stable subjects and subjects with IHAAE. 4. To calculate the sensitivity, specificity, positive predictive value and negative predictive value of the previously defined critical threshold for the normalized total blood volume of 65 ml/kg and the receiver operator characteristics for this threshold. 5. To compare measured total blood volume with calculated blood volume using Nadler*s formula

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)