The INCH-HD trial will test if incremental HD preserves the quality of life of patients and families and is a safe, practical, cost effective treatment option.
Kidney failure is a growing public health problem and fatal unless treated with dialysis or transplantation. Haemodialysis is the most common treatment for kidney failure in Australia and globally. Patients find haemodialysis extremely burdensome due to symptoms like fatigue, pain, cramps and poor quality of life that generally equates to \<60% of full health. Furthermore, haemodialysis is associated with an extremely high mortality (\<50% survive 5 years), particularly in the first 3-6 months of starting haemodialysis, which is likely linked to the rapid loss of patients' own kidney function when starting haemodialysis abruptly at three sessions/week. Observational studies suggest that starting haemodialysis incrementally at two sessions/ week is associated with lower mortality and better preservation of patients' remaining kidney function while offering many patient-important advantages, including dialysis free time and ability to work. However, robust evidence to recommend this incremental approach is lacking. The INCH-HD study is an investigator-initiated, international, multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial. The primary objective of the study is to demonstrate whether incremental HD is non-inferior to conventional HD for the patient-important outcome of quality of life measured using Kidney-specific component of the Kidney Disease Quality of Life - Short Form measurement (KDQOL-SF) at 6 months from dialysis commencement. The study will recruit a total of 372 participants across HD centres in Australia, and Canada. The outcomes of this trial will will provide urgently needed high quality evidence on whether starting haemodialysis incrementally at two sessions/week compared to the conventional three sessions/week can safely reduce the physical, financial and quality-of life burden on patients, lower early mortality rates and slow loss of kidney function while increasing haemodialysis capacity and reducing costs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
372
Starting haemodialysis at twice weekly frequency
Starting haemodialysis at thrice weekly frequency
Concord Repatriation General Hospital
Concord, New South Wales, Australia
NOT_YET_RECRUITINGNorthern Beaches Hospital
Frenchs Forest, New South Wales, Australia
Heath related quality of life
This will be measured using Kidney-specific component (KSC) of the Kidney Disease Quality of Life Short Form (KDQOL-SF) V1.3 questionnaire. The KSC is the mean of the 11 domains of the kidney-disease specific items of KDQOL-SF. Scores are transformed onto a 0-100 range, where a higher score reflects a better quality of life.
Time frame: 6 months
Residual kidney function (RKF)
Calculated as (creatinine clearance + kidney urea clearance) divided by 2 then corrected for body surface area using the DuBois method (0.20247 x (height in centimetres x 0.725) x (weight in kilograms x 0.425). Expressed as millilitres per minute (ml/min). Expected range 1 ml/min to 20 ml/min, where lower values indicate worse kidney function.
Time frame: Baseline, 3, 6, 12 and 18 months
Healthcare resource utilisation
Healthcare resource use over 18 months using linked data and patient monthly calendars
Time frame: Baseline to 18 months
Healthcare costs
Healthcare costs over 18 months using linked data and patient monthly calendars
Time frame: Baseline to 18 months
Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire
Heath-related quality of life will be measured using Kidney-specific component (KSC) of the Kidney Disease Quality of Life Short Form (KDQOL-SF) V1.3 questionnaire. The KSC is the mean of the 11 domains of the kidney-disease specific items of KDQOL-SF. Scores are transformed onto a 0-100 range, where a higher score reflects a better quality of life.
Time frame: Baseline, 3, 6, 9, 12, 15 and 18 months
Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire
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St George Hospital
Kogarah, New South Wales, Australia
NOT_YET_RECRUITINGLiverpool Hospital
Liverpool, New South Wales, Australia
NOT_YET_RECRUITINGJohn Hunter Hospital
New Lambton Heights, New South Wales, Australia
RECRUITINGRoyal North Shore Hospital
Saint Leonards, New South Wales, Australia
NOT_YET_RECRUITINGBundaberg Hospital
Bundaberg, Queensland, Australia
NOT_YET_RECRUITINGCairns Hospital
Cairns, Queensland, Australia
RECRUITINGRedland Hospital
Cleveland, Queensland, Australia
NOT_YET_RECRUITINGLogan Hospital
Logan City, Queensland, Australia
RECRUITING...and 6 more locations
Heath-related quality of life will be measured using EuroQol 5 Domain 5 Level (EQ-5D-5L) questionnaire. EQ-5D has descriptive and visual analogue scale (VAS). Descriptive system consists of five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. VAS records patient's self-rated health on vertical visual analogue scale with endpoints best to worst health with 0 being worst and 100 being best health.
Time frame: Baseline, monthly to 18 months
Incidence of all-cause mortality
Incidence of all-cause mortality up to 18 months
Time frame: Baseline to 18 months
Time to major cardiovascular event (MACE)
Time to first major cardiovascular event (MACE) up to 18 months
Time frame: Baseline to 18 months
Number of non-elective hospital admissions
Number of non-elective hospital admissions up to 18 months
Time frame: Baseline to 18 months
Total hospital days
Total hospital days up to 18 months
Time frame: Baseline to 18 months
Time to death
Time to death up to 18 months
Time frame: Baseline to 18 months
Number of hospital admissions
Number of hospital admissions up to 18 months
Time frame: Baseline to 18 months
Adverse events and side-effects
This will include episodes of hyperkalaemia, extra dialysis sessions for fluid overload, number of vascular access complications
Time frame: Baseline to 18 months
Symptom scores
This will be measured using change in the physical and mental component summaries of the Kidney Disease Quality of Life Short Form (KDQOL-SF) V1.3 questionnaire. This is scored using the mean of the physical and mental components of the KDQOL-SF. Scores are transformed onto a 0-100 range, where a higher score reflects a better quality of life.
Time frame: Baseline, 3, 6, 9, 12, 15 and 18 months
Fatigue
This will be measured using the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) Fatigue questionnaire. The SONG-HD Fatigue measure consists of three items that assess the effect of fatigue on life participation, tiredness, and level of energy. The overall score for fatigue is obtained by summing the responses across the three questions, resulting in a scale ranging from zero (no fatigue) to nine (maximum fatigue).
Time frame: Baseline, 3, 6, 9, 12, 15 and 18 months
Nutritional Status
This will be measured using the Subjective Global Assessment (SGA) of nutrition which is scored as proportion of well nourished (A) versus malnourished (B or C). A (well nourished), B (mildly-moderately malnourished), C (Severely malnourished)
Time frame: Baseline, 6, 12 and 18 months
Vascular access
This will be measured as mumber of functional vascular access interventions required per patient per year to enable and /or maintain vascular access for HD per patient-year
Time frame: Baseline to 18 months