Use of HA 330-II for Hemofiltration in Patients With ALF as a Bridge to Liver Transplantation .
Palabras clave
Abstracto
Descripción
Since the 1960s, Liver Transplantation (LT) has emerged as a cornerstone intervention to cure liver failure. Mortality in patients with liver failure who cannot be rescued with Liver Transplantation remains high despite improvements in supportive care.
Artificial Liver Support System (ALSS) in ALF aim to remove excess inflammatory cytokines and attenuate inflammatory response, to remove albumin-bound and water-soluble toxins, to restore and preserve hepatic function and mitigate or limit the progression of multiorgan failure while hepatic recovery or liver transplant occurs. ALSS may also provide benefit in instances where LT is contraindicated.
The following beneficial effects have been documented with ALSS in ALF patients: improvement of jaundice, amelioration of hemodynamic instability, improvement of hepatic encephalopathy, SOFA score and survival.
HA 330-II is a broad-spectrum adsorbent made of neutral macroporous resin, removes toxins such as Inflammatory mediators (IL-1, IL-6, IL-8 & TNF-α) along with hepatic toxins such as phenol, mercaptan, aromatic amino acids, false neurotransmitters and indirectly ammonia by improving liver function recovery. However, this indirect ammonia removal with HA 330-II is insignificant. By removing excess inflammatory cytokines and attenuating uncontrolled immune response, HA 330-II prevents worsening of encephalopathy, improves liver function recovery and improves prognosis.
fechas
| Verificado por última vez: | 12/31/2019 |
| Primero enviado: | 01/16/2020 |
| Inscripción estimada enviada: | 01/23/2020 |
| Publicado por primera vez: | 01/27/2020 |
| Última actualización enviada: | 01/23/2020 |
| Última actualización publicada: | 01/27/2020 |
| Fecha de inicio real del estudio: | 12/29/2019 |
| Fecha estimada de finalización primaria: | 09/30/2020 |
| Fecha estimada de finalización del estudio: | 12/30/2020 |
Condición o enfermedad
Intervención / tratamiento
Device: Hemoperfusion treatment with HA 330-II
Drug: Standard medical treatment (SMT)
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Hemoperfusion treatment with HA 330-II Hemoperfusion treatment with HA 330-II, one unit for 2-4 hours treatment, for 3 consecutive days along with SMT as per patients requirement. | Device: Hemoperfusion treatment with HA 330-II One unit for 2-4 hours treatment, for 3 consecutive days |
| Active Comparator: Standard medical treatment (SMT) SMT as per patients requirement- Management of cerebral edema/intracranial hypertension: prophylactic antibiotics, administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, volume replacement and pressor support (noradrenaline, doubutamine, dopamine) as needed, NAC and correction of metabolic parameters. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: • Acute Liver Failure patients with SIRS and Hepatic Encephalopathy, without hyperbilirubinemia. Exclusion Criteria: - Patients with age less than 18 years or more than 65 years - Extremely moribund patients with an expected life expectancy of less than 24 hours or with poor prognosis - With poor blood clotting function and PTA <30%. - Active Bleed - Chronic heart, lung or kidney disease - Malignant tumors including liver cancer - Past history of organ transplantation |
Salir
Medidas de resultado primarias
1. Efficacy of HA 330-II to prolong liver-transplantation free survival. [Up to 30 Days]
Medidas de resultado secundarias
1. Change in Systemic inflammatory response syndrome (SIRS) score. [Up to 7 Days, post hemofiltration]
2. Change in Acute Physiology and Chronic Health Evaluation (APACHE-II) score. [Up to 7 Days, post hemofiltration]
3. Change in sequential organ failure assessment (SOFA) score. [Up to 7 Days, post hemofiltration]
4. Change in chronic liver failure-sequential organ failure assessment (CLIF-SOFA) score. [Up to 7 Days, post hemofiltration]
