Study to investigate changes in blood pressure with different types of kidney dialysis treatments

Study To Investigate The Change In Hypotensive Episodes during Dialysis (STITCHED)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN74893205

Enrollment

346

Registered

2019-03-28

Start date

2019-04-15

Completion date

Unknown

Last updated

2022-08-05

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

Conditions

Kidney failure treated by haemodialysis Urological and Genital Diseases Renal failure

Interventions

Measured at study entry and at 24 months: 1. Ambulatory blood pressure and pulse wave velocity 2. Trans-thoracic echocardiography 3. Bioimpedance 4. Montreal Cognitive Assessment 5. Beta-2 microglobu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients randomised to The UK High-flux Haemodialysis vs High-volume Haemodiafiltration Registry Trial (H4RT) National Institute Health Research (NIHR) Health Technology Assessment 15/80/52

Exclusion criteria

Exclusion criteria: 1. Not enrolled in H4RT study 2. Unable to provide informed consent

Design outcomes

Primary

Measure	Time frame
Intra-dialytic hypotensive episodes recorded quarterly	—

Secondary

Measure	Time frame
1. Ambulatory blood pressure measured at study entry, 12 months and completion at 24 months 2. Arterial stiffness measured using pulse wave velocity (pressure mmHg) at study entry, 12 months and completion at 24 months 3. Cognitive function assessed using Montreal cognitive assessment at study entry, 12 months and completion at 24 months 4. Extracellular water volumes measured using bioimpedance (volume L) at study entry, 12 months and completion at 24 months 5. Cardiac biomarkers measured using lab test at study entry, 12 months and completion at 24 months 6. Cardiac echocardiographic parameters and function measured using transthoracic echocardiogram at study entry and study completion at 24 months 7. Clearance of the middle molecule ß2 microglobulin measured using lab test at study entry, 12 months and completion at 24 months	—

Measure

Time frame

1. Ambulatory blood pressure measured at study entry, 12 months and completion at 24 months 2. Arterial stiffness measured using pulse wave velocity (pressure mmHg) at study entry, 12 months and completion at 24 months 3. Cognitive function assessed using Montreal cognitive assessment at study entry, 12 months and completion at 24 months 4. Extracellular water volumes measured using bioimpedance (volume L) at study entry, 12 months and completion at 24 months 5. Cardiac biomarkers measured using lab test at study entry, 12 months and completion at 24 months 6. Cardiac echocardiographic parameters and function measured using transthoracic echocardiogram at study entry and study completion at 24 months 7. Clearance of the middle molecule ß2 microglobulin measured using lab test at study entry, 12 months and completion at 24 months

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026