Phase III clinical evaluation of WBCRRD and SPB-KT in patients receiving continuous blood purification therapy (CBP)

JRCT ID: jRCT2031230572

Registered date:18/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who need continuous blood purification therapy
• Date of first enrollment: 27/09/2023
• Target sample size: 344
• Study type: Interventional
• Intervention(s): Research subjects receive continuous blood purification therapy using investigational drug WBCRRD or SPB-KT, according to random assignment. During the investigational treatment, the examinations and observations specified in the protocol are conducted.

Outcome(s)

• Primary Outcome: Both of serum potassium level and serum sodium level are corrected or maintained within the target control range.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

- Written informed consent from patients or legal representative if patients lack of ability to consent.
- Over 20 years of age at the time of acquiring consent.
- Indications: Fluid overload, Metabolic acidosis, Urine output, Electrolytes disturbance, Intoxication, Cytokine abnormal, Severe pancreatitis acute, Hepatitis fulminant or Postoperative hepatic failure.
, etc.

Exclude criteria

- Patients who find it difficult to receive treatment under the conditions specified in the study protocol.
- Patients who are pregnant at the time of consent for this study.
- Patients participating in other clinical studies at the time of consent for this study.
- Patients judged to be inadequate for this study by the investigators .
, etc.

Related Information

• Primary Sponsor: Kinoshita Kaori