xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026267</url>
    </required_header>
    <id_info>
      <org_study_id>ILBS-Cirrhosis-59</org_study_id>
      <nct_id>NCT06026267</nct_id>
    </id_info>
    <brief_title>Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis</brief_title>
    <official_title>Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Liver and Biliary Sciences, India</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Liver and Biliary Sciences, India</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with&#xD;
        Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been&#xD;
        clearly defined, which decreases the morbidity and mortality. However the conventional dose&#xD;
        recommended by the guidelines is usually not tolerated by the Indian population. Investigator&#xD;
        propose that the low dose is as beneficial as the standard dose in patients with high risk&#xD;
        SBP in the prevention/progression of renal dysfunction in cirrhotic patients with high risk&#xD;
        spontaneous bacterial peritonitis. If confirmed, these results could support a significant&#xD;
        cost reduction in the management of ascites in cirrhotic patients and decrease the side&#xD;
        effects of the volume overload in the patient of the cirrhosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hypothesis Alternate Hypothesis: Low dose albumin is as effective as conventional dose&#xD;
        albumin in cirrhosis with high risk SBP patients having AKI development or progression by day&#xD;
        4.&#xD;
  &#xD;
        Aim:-To compare the efficacy and safety of low dose albumin with conventional dose albumin in&#xD;
        AKI development or progression in patients with cirrhosis and high risk spontaneous bacterial&#xD;
        peritonitis.&#xD;
  &#xD;
        Study population: Patients of age &gt; 18 years of age with cirrhosis of liver who are admitted&#xD;
        in ward/ICU diagnosed with high risk SBP.&#xD;
  &#xD;
        Study design: Randomized controlled trial Study period:1.5year Sample size: 300 (150 cases in&#xD;
        each group) Assuming that the rate of AKI development in conventional dose albumin group -&#xD;
        10% and low dose albumin group 15%, Power- 80%, Alpha- 10% ONE SIDED, Non inferiority limit-&#xD;
        5, cases needed to enroll are 270, further assuming 10% dropout, investigator decided to&#xD;
        enroll total 300 cases, randomly allocated with 150 cases in each arm by block randomization&#xD;
        method with Block size of 10 Cases will be randomly allocated in 2 groups by block&#xD;
        randomization method with block size taken as 10.&#xD;
  &#xD;
        STATISTICAL ANALYSIS:&#xD;
  &#xD;
        Continuous variables- Mean +/- SD Categorical variables as percentages (%) or Frequencies&#xD;
        Student t test will be applied in continuous data compared with two groups Survival analysis&#xD;
        like Cox-Regression model and Kaplan-Meir plots will be plotted to find the possible factors&#xD;
        responsible for mortality Besides these, Intent to treat (ITT) and Per Protocol (PP) will be&#xD;
        done at the time of data analysis.&#xD;
  &#xD;
        Adverse effects:&#xD;
  &#xD;
        Patients receiving Albumin may experience Nausea, Vomiting, Fever with chills, dyspnea&#xD;
        Wheezing, Volume overload, Anaphylactic reaction&#xD;
  &#xD;
        Stopping rule of study:&#xD;
  &#xD;
        Adverse reaction to drug Cardiopulmonary compromise&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patients developing new AKI or having progression of AKI by day 4.</measure>
      <time_frame>Day 4</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Resolution of Spontaneous Bacterial Peritonitis by day 5</measure>
      <time_frame>Day 5</time_frame>
      <description>Resolution is defined as decrease in ascitic fluid PMN &gt; 25% from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on Serum Ascites Albumin Gradient (SAAG) in both the groups.</measure>
      <time_frame>Day 5</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in cell count (PMN) in both groups.</measure>
      <time_frame>Day 5</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in PRA levels from baseline to day 7</measure>
      <time_frame>day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in TNF-alpha levels from baseline to day 7</measure>
      <time_frame>day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in IL-6 levels from baseline to day 7</measure>
      <time_frame>day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in endotoxin levels from baseline to day 7</measure>
      <time_frame>day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in renal resistive index from baseline to day 7</measure>
      <time_frame>day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with development of complications in both groups</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with changes in ProBNP from baseline to day 4 or if shortness of breath occurs</measure>
      <time_frame>Day 4</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with changes in vWF-Ag from baseline to day 4</measure>
      <time_frame>Day 4</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients expired in both the groups</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients expired in both the groups</measure>
      <time_frame>Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients expired in both the groups</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of hospital stay</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Liver Cirrhosis</condition>
    <condition>Spontaneous Bacterial Peritonitis</condition>
    <arm_group>
      <arm_group_label>High Dose Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg body weight (Maximum 100g)on day 3 along with standard medical therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Reduced Dose Albumin+Standard Medical therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Human Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>20% High Dose Albumin</intervention_name>
      <description>A]. Patients in the conventional albumin Arm will receive Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg bodyweight (Maximum 100g)on day 3 along with standard medical therapy</description>
      <arm_group_label>High Dose Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard Medical Treatment</intervention_name>
      <description>Standard Medical Treatment</description>
      <arm_group_label>High Dose Arm</arm_group_label>
      <arm_group_label>Reduced Dose Albumin+Standard Medical therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>20% Reduced Dose Albumin</intervention_name>
      <description>B]. Patients in the low dose albumin Arm will receive Human Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy</description>
      <arm_group_label>Reduced Dose Albumin+Standard Medical therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age &gt;18years&#xD;
  &#xD;
            2. Cirrhosis with SBP (community acquired /Health care associated/ nosocomial)&#xD;
  &#xD;
            3. High risk SBP : Patients with S Bil &gt;4 mg/dL and/or s creat &gt; 1 mg/dl at presentation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Antibiotic treatment within one week before the diagnosis of SBP (except for&#xD;
               prophylactic treatment with norfloxacin)&#xD;
  &#xD;
            2. Significant cardiac failure, pulmonary disease&#xD;
  &#xD;
            3. Known CKD or findings suggestive of organic nephropathy (proteinuria, haematuria, or&#xD;
               abnormal findings on renal USG)&#xD;
  &#xD;
            4. Hepatocellular carcinoma&#xD;
  &#xD;
            5. HIV infection&#xD;
  &#xD;
            6. GI bleed within 1 month before the study&#xD;
  &#xD;
            7. Grade 3 to 4 hepatic encephalopathy&#xD;
  &#xD;
            8. Shock (MAP &lt; 65)&#xD;
  &#xD;
            9. Serum creatinine level of &gt; 3 mg/decilitre&#xD;
  &#xD;
           10. Presence of any potential causes of dehydration (such as diarrhea or an intense&#xD;
               response to diuretic treatment within one week before the diagnosis of SBP).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dr Sourav Paul, MD</last_name>
      <phone>01146300000</phone>
      <email>saurav.paul79@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institute of Liver &amp; Biliary Sciences</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110070</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Saurabh Paul, MD</last_name>
        <phone>01146300000</phone>
        <email>saurav.paul79@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peritonitis</mesh_term>
      <mesh_term>Liver Cirrhosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026267
  org study id: ILBS-Cirrhosis-59
  nct id: NCT06026267
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with
        Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been
        clearly defined, which decreases the morbidity and mortality. However the conventional dose
        recommended by the guidelines is usually not tolerated by the Indian population. Investigator
        propose that the low dose is as beneficial as the standard dose in patients with high risk
        SBP in the prevention/progression of renal dysfunction in cirrhotic patients with high risk
        spontaneous bacterial peritonitis. If confirmed, these results could support a significant
        cost reduction in the management of ascites in cirrhotic patients and decrease the side
        effects of the volume overload in the patient of the cirrhosis.
  Hypothesis Alternate Hypothesis: Low dose albumin is as effective as conventional dose
        albumin in cirrhosis with high risk SBP patients having AKI development or progression by day
        4.
  
        Aim:-To compare the efficacy and safety of low dose albumin with conventional dose albumin in
        AKI development or progression in patients with cirrhosis and high risk spontaneous bacterial
        peritonitis.
  
        Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted
        in ward/ICU diagnosed with high risk SBP.
  
        Study design: Randomized controlled trial Study period:1.5year Sample size: 300 (150 cases in
        each group) Assuming that the rate of AKI development in conventional dose albumin group -
        10% and low dose albumin group 15%, Power- 80%, Alpha- 10% ONE SIDED, Non inferiority limit-
        5, cases needed to enroll are 270, further assuming 10% dropout, investigator decided to
        enroll total 300 cases, randomly allocated with 150 cases in each arm by block randomization
        method with Block size of 10 Cases will be randomly allocated in 2 groups by block
        randomization method with block size taken as 10.
  
        STATISTICAL ANALYSIS:
  
        Continuous variables- Mean +/- SD Categorical variables as percentages (%) or Frequencies
        Student t test will be applied in continuous data compared with two groups Survival analysis
        like Cox-Regression model and Kaplan-Meir plots will be plotted to find the possible factors
        responsible for mortality Besides these, Intent to treat (ITT) and Per Protocol (PP) will be
        done at the time of data analysis.
  
        Adverse effects:
  
        Patients receiving Albumin may experience Nausea, Vomiting, Fever with chills, dyspnea
        Wheezing, Volume overload, Anaphylactic reaction
  
        Stopping rule of study:
  
        Adverse reaction to drug Cardiopulmonary compromise
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of patients developing new AKI or having progression of AKI by day 4.
  time frame: Day 4
  measure: Resolution of Spontaneous Bacterial Peritonitis by day 5
  time frame: Day 5
  description: Resolution is defined as decrease in ascitic fluid PMN > 25% from baseline
  measure: Change on Serum Ascites Albumin Gradient (SAAG) in both the groups.
  time frame: Day 5
  measure: Change in cell count (PMN) in both groups.
  time frame: Day 5
  measure: Changes in PRA levels from baseline to day 7
  time frame: day 7
  measure: Changes in TNF-alpha levels from baseline to day 7
  time frame: day 7
  measure: Changes in IL-6 levels from baseline to day 7
  time frame: day 7
  measure: Changes in endotoxin levels from baseline to day 7
  time frame: day 7
  measure: Changes in renal resistive index from baseline to day 7
  time frame: day 7
  measure: Number of patients with development of complications in both groups
  time frame: 90 days
  measure: Number of Participants with changes in ProBNP from baseline to day 4 or if shortness of breath occurs
  time frame: Day 4
  measure: Number of Participants with changes in vWF-Ag from baseline to day 4
  time frame: Day 4
  measure: Number of patients expired in both the groups
  time frame: Day 7
  measure: Number of patients expired in both the groups
  time frame: Day 28
  measure: Number of patients expired in both the groups
  time frame: Day 90
  measure: Duration of hospital stay
  time frame: 90 days
  arm group label: High Dose Arm
  arm group type: Experimental
  description: Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg body weight (Maximum 100g)on day 3 along with standard medical therapy.
  arm group label: Reduced Dose Albumin+Standard Medical therapy
  arm group type: Active Comparator
  description: Human Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy.
  intervention type: Biological
  intervention name: 20% High Dose Albumin
  description: A]. Patients in the conventional albumin Arm will receive Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg bodyweight (Maximum 100g)on day 3 along with standard medical therapy
  arm group label: High Dose Arm
  intervention type: Other
  intervention name: Standard Medical Treatment
  description: Standard Medical Treatment
  arm group label: High Dose Arm
  arm group label: Reduced Dose Albumin+Standard Medical therapy
  intervention type: Biological
  intervention name: 20% Reduced Dose Albumin
  description: B]. Patients in the low dose albumin Arm will receive Human Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy
  arm group label: Reduced Dose Albumin+Standard Medical therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Dr Sourav Paul, MD
  phone: 01146300000
  email: saurav.paul79@gmail.com
  facility: 
  contact: 
  country: India
  responsible party type: Sponsor
  mesh term: Peritonitis
  mesh term: Liver Cirrhosis
  mesh term: Fibrosis
  sharing ipd: Undecided