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Taking people in IndiaPhase 4

Compares two dialysis salt levels in people with kidney failure

Tests two dialysis sodium levels in adults receiving maintenance haemodialysis for kidney failure.

Plain-language title generated from the registry record
Registry title: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Key facts

Where
Ambāla, Balasore, Bengaluru, Bhetia, Bhubaneswar, Bokāro, Borivali West, Chennai, Chīrāla, Coimbatore, Dhanbad, Gūdūr, Guntur, Hindupur PPP, Hubli, Hyderabad, Indore, Kākināda, Kanigiri, Kanpur, Khammam, Kilpauk, Kolathūr, Kolkata, Kothagudem, Kurnool, Lucknow, Ludhiana, Machilipatnam, Mārkāpur, Mumbai, Nalgonda, Nandyāl, Narsīpatnam, Neyveli, Noida, Old Palasia, Palakonda, Srikakulam District, Palāsa, Pārvathipuram, Patna, Proddatūr, Pune, Rajahmundry, Ranchi, Secunderabad, Sompeta, Srikakulam, Tadepalligudem, Tamlūk, Thane, Tirupati, Uttar Mechgram, Vijayawada, and Visakhapatnam, IndiaSee the 63 sites
Phase
Phase 4

Where in India

  • Leelawati HospitalAmbāla, IndiaTaking people
  • Jyothi HospitalBalasore, IndiaTaking people
  • Koshys Hospital, Ramamurthy NagarBengaluru, IndiaTaking people
  • Nephroplus BasaveshwaranagarBengaluru, IndiaTaking people
  • ESI HospitalBhetia, IndiaTaking people
  • Kar Clinic & Hospital Pvt. Ltd.Bhubaneswar, IndiaTaking people
  • Neelachal Hospital, Kharvel NagarBhubaneswar, IndiaTaking people
  • K.M Memorial Hospital and Research CentreBokāro, IndiaTaking people
  • Bharat BaugBorivali West, IndiaTaking people
  • Nephroplus Borivali StandaloneBorivali West, IndiaTaking people
  • Deepam Hospitals, PallavaramChennai, IndiaTaking people
  • Area Hospital, Kothapeta Road,Chirala, Andhra PradeshChīrāla, IndiaTaking people
  • KG HospitalCoimbatore, IndiaTaking people
  • Asarfi HospitalDhanbad, IndiaTaking people
  • Medical Superintendent Government HospitalGūdūr, IndiaTaking people
  • Government General HospitalGuntur, IndiaTaking people
  • Medical Superintendent District HospitalHindupur PPP, IndiaTaking people
  • Fortis Suchirayu HospitalHubli, IndiaTaking people
  • Citizens Specialty HospitalHyderabad, IndiaTaking people
  • ESI Multi-Specialty HospitalHyderabad, IndiaTaking people
  • Vintage Plaza Nephroplus, Road no. 10, Banjara HillsHyderabad, IndiaTaking people
  • Vishesh Hospital Pvt. Ltd, Geeta Bhawan ChourahaIndore, IndiaTaking people
  • Government HospitalKākināda, IndiaTaking people
  • Government Area Hospital, Kanigiri, Andhra PradeshKanigiri, IndiaTaking people
  • Madhuraj HospitalKanpur, IndiaTaking people
  • Government HospitalKhammam, IndiaTaking people
  • Aysha HospitalKilpauk, IndiaTaking people
  • Retteri Sri Kumaran Health CentreKolathūr, IndiaTaking people
  • Health Point Hospital, Prannth Pandit StreetKolkata, IndiaTaking people
  • Main Hospital, SCCLKothagudem, IndiaTaking people
  • Government General HospitalKurnool, IndiaTaking people
  • Ajanta HospitalLucknow, IndiaTaking people
  • Satguru Partap Singh Apollo HospitalsLudhiana, IndiaTaking people
  • Government Hospital, Machilipatnam PPP, Andhra PradeshMachilipatnam, IndiaTaking people
  • Government Area HospitalMārkāpur, IndiaTaking people
  • Hitwardhak Mandal HospitalMumbai, IndiaTaking people
  • Suraksha Multispecialty HospitalNalgonda, IndiaTaking people
  • Government HospitalNandyāl, IndiaTaking people
  • Area HospitalNarsīpatnam, IndiaTaking people
  • Neyveli Lignite Corporation HospitalNeyveli, IndiaTaking people
  • Sudha Hospital, VadalurNeyveli, IndiaTaking people
  • Surbhi Hospital Pvt. Ltd, Sector 35Noida, IndiaTaking people
  • Greater Kailash HospitalOld Palasia, IndiaTaking people
  • Government Area HospitalPalakonda, Srikakulam District, IndiaTaking people
  • CHC Government HospitalPalāsa, IndiaTaking people
  • Government Area HospitalPārvathipuram, IndiaTaking people
  • Ford Hospital, Khemnichak, PatnaPatna, IndiaTaking people
  • Janak Dulari Hospital, Hanuman NagarPatna, IndiaTaking people
  • Government HospitalProddatūr, IndiaTaking people
  • Lokmanya HospitalPune, IndiaTaking people
  • Government HospitalRajahmundry, IndiaTaking people
  • Bhagwan Mahavir Medical Superspeciality HospitalRanchi, IndiaTaking people
  • Guru Nanak Hospital and Research CentreRanchi, IndiaTaking people
  • Nephroplus Standalone Dialysis Center, Easy MarredpallySecunderabad, IndiaTaking people
  • CHC Hospital, Sompeta, Andhra PradeshSompeta, IndiaTaking people
  • Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, AndhraSrikakulam, IndiaTaking people
  • Greater Kailash HospitalTadepalligudem, IndiaTaking people
  • Minimal Access Surgery Clinic Pvt LtdTamlūk, IndiaTaking people
  • Chirayu HospitalThane, IndiaTaking people
  • Manasa Kidney FoundationTirupati, IndiaTaking people
  • Baroma Sirona HospitalUttar Mechgram, IndiaTaking people
  • Government General Hospital, Vijayavada PPP, Andhra PradeshVijayawada, IndiaTaking people
  • King George Government HospitalVisakhapatnam, IndiaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Sydney
Trial code
NCT02823821
Record updated
4 April 2025
Original description
This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.Read full original descriptionShow less

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

The site inclusion criteria are:; Predominantly dialyses adults (≥18 years old) receiving maintenance haemodialysis; Rates of withdrawal within the first two years of commencing dialysis for social reasons have been less than 15% for the 2 years prior to recruitment and are not expected to increase above 15%; Has a minimum of 10 dialysis recipients at time of randomisation; Utilises a default dialysate sodium concentration at the time of recruitment (a substantial majority of dialysis sessions are conducted with the default dialysate sodium concentration); Is a self-contained unit (i.e. unit patients do not regularly rotate through another unit. Brief trips by patients to a parent or other unit do not exclude a site); Willing to accept randomisation to either intervention (as determined by nominated Director of Unit); Is not a home dialysis training or support unit. [Sites that include both in-center/satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter/satellite component of the site]; The exclusion criteria are:; Not able to comply with data collection methods.

ClinicalTrials.gov NCT02823821