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Effects of Dialysate/Replacement Supraphysiologic Sodium Concentration and Hemodynamic Stability in Critically-ill Patients receiving Continuous Renal Replacement Therapy (CRRT) : A Randomized, Double-blinded, Controlled Study

Effects of Dialysate/Replacement Supraphysiologic Sodium Concentration and Hemodynamic Stability in Critically-ill Patients receiving Continuous Renal Replacement Therapy (CRRT) : A Randomized, Double-blinded, Controlled Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200108001
Enrollment
64
Registered
2020-01-08
Start date
2020-01-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Critically&#45

Interventions

Accusol&#45
35 will be used as a replacement fluid. The component of this fluid include [Na+] 140 mmol/L&#44
[K+] 0 mmol/L&#44
[Cl&#45
] 109.5 mmol/L&#44
[HCO3&#45
] 35 mmol/L&#44
[Mg2+] 0.5 mmol/L&#44
and [Ca2+] 1.75 mmol/L. ,High&#45
sodium replacement fluid will be generated by a mix of Accusol&#45
35 5&#44
000 ml and 3% NaCl 100 ml. The component of this mixing fluid will include [Na+] 147.3 mmol/L&#44
] 117.4 mmol/L&#44
] 34.3 mmol/L&#44
[Mg2+] 0.49 mmol/L&#44
and [Ca2+] 1.72 mmol/L.
Active Comparator Other,Experimental Other

Sponsors

Division of Nephrology, Department of Internal Medicine, Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age of 18 years or more 2. ICU patients requiring continuous renal replacement therapy 3. Patients with adequate volume status assessed by inferior vena cava distensibility index <18 % or pulse pressure variation < 13 % 4. Patients who are being on inotropic agents 5. Patients or family members can provide consent

Exclusion criteria

Exclusion criteria: 1. Patients with serum sodium levels <125 mmol/L 2. Patients with mean arterial pressure <65 mmHg with adequate dose of inotropic agents 3. Patients with severe acidosis (defined by blood pH <7.15) 4. Pregnancy 5. Uncontrolled bleeding

Design outcomes

Primary

MeasureTime frame
Percentage of patients who have vasopressor dependency index change of ≥0.05 4 hours after randomization Vasopressor dependency index is calculated from inotropic score divided by mean arterial pressure

Secondary

MeasureTime frame
Percentage of patients who have vasopressor dependency index change of ≥0.05 8&#44; 16&#44; and 24 hours after randomization Vasopressor dependency index is calculated from inotropic score divided by mean arterial pressure,Changes of mean arterial blood pressure from baseline 4&#44; 8&#44; 16&#44; and 24 hours after randomization Blood pressure is measured by standard methods with automatic machine,Changs of blood lactate from baseline 8 hours after randomization Blood lactate is measured by hospital central laboratory unit using standard technique,์Number of days using inotropic agents From randomization until reach endpoint of interest or patient death Number of days counting from randomization to the last day using inotropic agents,์Number of days requiring continuous dialysis therapy From randomization until reach endpoint of interest or patient death Number of days counting from randomization to the last day requiring continuous dialysis therapy,Mortality rate at day 7 and day 28 after randomization and in&#45;hospital Declaration of in&#45;hospital death by attending physicians

Countries

Thailand

Contacts

Public ContactKajohnsak Noppakun

Chiang Mai University

kajohnsak.noppakun@cmu.ac.th66-81-595-3465

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026