Health TrialsbyHealthPanel

INCREmental DIalysis and Diet for a Better Life Experience

ConditionIncremental Haemodialysis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier le Mans

About this trial

Previous studies suggest that the supplementation of essential amino acids and ketaoacids may prolong the duration of the incremental phase of peritoneal dialysis. There is no data on incremental haemodialysis patients. Such data would be highly needed to support the management of haemodialysis patients in the transition phase from "pre-dialysis" to "full dose" dialysis. In this context, investigator proposed a randomized "add on" trial, to evaluate the effect of the addition of Ketosteril to the usual nutritional plan to patients who start haemodialysis in incremental way.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (aged 18 years or older)

Able and accepting to give informed consent

Starting iHD in the Centre Hospitalier Le Mans

Disqualifiers

Denying informed consent

Acute kidney injury (AKI)

Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months

Cognitive impairment severe enough to limit understanding and acceptance of the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Supplementation by ketosteril

    Drug

    1 tablet each 10 kg of ideal Body Weight is dispensed per day

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Control armNo intervention 0 interventions
Group B: Interventional armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Duration of incremental haemodialysis period

Duration in months of the incremental haemodialysis period (defined as less than 3 times per week but excluding the cases in which dialysis frequency is reduced in the context of palliative and end-of life care)

Time frame
24 months

Secondary outcomes

1

Mortality

Number of patients who have died (patients who discontinue dialysis in the context of an "end of life care project" are considered as deceased at the start of the program of palliative care)

Time frame
24 months
2

Hospitalization rates

Hospitalization rates (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care.

Time frame
24 months
3

Combined outcome mortality and hospitalization

Time frame
24 months
4

Quality of life

Quality of life is assessed by questionnaire WHO QoL (from 26 to 130, the higher the score, the better the quality of life)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier le Mans

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: