<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/NCT04406506</url>
  </required_header>
  <id_info>
    <org_study_id>ICU-28-20</org_study_id>
    <nct_id>NCT04406506</nct_id>
  </id_info>
  <brief_title>Entral Feeding in Acute Severe Pancreatitis</brief_title>
  <official_title>Comparative Study Between Different Methods of Enteral Feeding in Acute Severe Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdul Aziz Specialist Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdul Aziz Specialist Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      • A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018&#xD;
      and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with&#xD;
      the following inclusion criteria: Abdominal pain &gt; 6 on the visual analogue scale without&#xD;
      given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at&#xD;
      least 3 times the upper limit of the reference range (considering normal lipase level from&#xD;
      0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized&#xD;
      axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed&#xD;
      pancreatic picture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The study was conducted on monitoring of four pillar for 13 days (data collected one day&#xD;
           before feeding and every three days for 12 days). the first pillar comparing the effect&#xD;
           of the two enteral feeding methods on the clinical condition of the acute severe&#xD;
           pancreatitis and this monitored clinically and laboratory by fixed parameters,&#xD;
           clinically, by abdominal pain which assessed by visual analogue scale (VAS). and&#xD;
           laboratory, by both markers of severity of pancreatic acini destruction which assessed&#xD;
           by serum amylase, lipase and Markers of severity of interstitial pancreatic tissue&#xD;
           destruction which assessed by the level of Lactate Dehydrogenase level (LDH), Aspartate&#xD;
           aminotransferase (AST), C-reactive protein, prostacyclin and interleukin 8. The second&#xD;
           pillar include effect of the two enteral feeding methods on the patient's tolerance and&#xD;
           these monitored in our study by both post-feeding vomiting and post feeding attacks of&#xD;
           osmotic diarrhea and also abdominal pain. Third pillar include effect of the two enteral&#xD;
           feeding methods on the patient's general condition and these monitored by follows the&#xD;
           APACHE II Score, hemodynamics of the patients in both groups (Mean arterial blood&#xD;
           pressure and pulse) and arterial oxygen saturation (Spo2). Fourth pillar include effect&#xD;
           of the two enteral feeding methods on achieving satisfactory nutrition parameters of the&#xD;
           patients and both albumin level, radium blood sugar and electrolytes (sodium and&#xD;
           potassium level) used as indicator for this.&#xD;
&#xD;
        -  All parameters observed one day before starting feeding and every 3 days for 12 days&#xD;
           (duration of the study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2018</start_date>
  <completion_date type="Actual">April 10, 2020</completion_date>
  <primary_completion_date type="Actual">April 2, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>13 Days</target_duration>
  <primary_outcome>
    <measure>effect of different methods of feeding in the clinical condition of the acute severe pancreatitis</measure>
    <time_frame>13 days</time_frame>
    <description>first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis,The second pillar include effect of the two enteral feeding methods on the patient's tolerance</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Nausea</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Group A received nasogastric feeding (NG), insure through ngt pump</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>receive feeding throughThe nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.&#xD;
Patients were placed in right lateral position</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>nasogastric</intervention_name>
    <description>• The insertion of NG tubes were performed by the ICU physician and the position was checked by auscultation of gas from 50 ml syringe by injecting 20 ml of air in the NG and by X-ray abdomen to be sure from the site of NG tube</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>nasojejunal</intervention_name>
    <description>The nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.&#xD;
Patients were placed in right lateral position</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(erythromycin 250 mg IV bolus)</intervention_name>
    <description>prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June&#xD;
             2018 and April 2020 with both a clinical and biochemical presentation of acute&#xD;
             pancreatitis with the following inclusion criteria: Abdominal pain &gt; 6 on the visual&#xD;
             analogue scale without given analgesia , abdominal distension and tenderness with&#xD;
             serum amylase and serum lipase at least 3 times the upper limit of the reference range&#xD;
             (considering normal lipase level from 0-160 U/L, and normal amylase level from 0-100&#xD;
             U/L) with confirmed abdominal computerized axial tomography of grade D and E on Ranson&#xD;
             and colleagues criteria(28) of inflamed pancreatic picture.&#xD;
&#xD;
          -  An acute physiology and chronic health evaluation (APACHE) II were done for all of&#xD;
             them and only score of &gt; 8 included in our study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute pancreatitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic disease as hypertension or diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>King abd el Aziz specialist hospital</name>
      <address>
        <city>Ta'if</city>
        <zip>21944</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</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>Pancreatitis</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erythromycin</mesh_term>
    <mesh_term>Erythromycin Estolate</mesh_term>
    <mesh_term>Erythromycin Ethylsuccinate</mesh_term>
    <mesh_term>Erythromycin stearate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04406506
org study id: ICU-28-20
nct id: NCT04406506
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
• A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018
      and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with
      the following inclusion criteria: Abdominal pain > 6 on the visual analogue scale without
      given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at
      least 3 times the upper limit of the reference range (considering normal lipase level from
      0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized
      axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed
      pancreatic picture.
-  The study was conducted on monitoring of four pillar for 13 days (data collected one day
           before feeding and every three days for 12 days). the first pillar comparing the effect
           of the two enteral feeding methods on the clinical condition of the acute severe
           pancreatitis and this monitored clinically and laboratory by fixed parameters,
           clinically, by abdominal pain which assessed by visual analogue scale (VAS). and
           laboratory, by both markers of severity of pancreatic acini destruction which assessed
           by serum amylase, lipase and Markers of severity of interstitial pancreatic tissue
           destruction which assessed by the level of Lactate Dehydrogenase level (LDH), Aspartate
           aminotransferase (AST), C-reactive protein, prostacyclin and interleukin 8. The second
           pillar include effect of the two enteral feeding methods on the patient's tolerance and
           these monitored in our study by both post-feeding vomiting and post feeding attacks of
           osmotic diarrhea and also abdominal pain. Third pillar include effect of the two enteral
           feeding methods on the patient's general condition and these monitored by follows the
           APACHE II Score, hemodynamics of the patients in both groups (Mean arterial blood
           pressure and pulse) and arterial oxygen saturation (Spo2). Fourth pillar include effect
           of the two enteral feeding methods on achieving satisfactory nutrition parameters of the
           patients and both albumin level, radium blood sugar and electrolytes (sodium and
           potassium level) used as indicator for this.

        -  All parameters observed one day before starting feeding and every 3 days for 12 days
           (duration of the study).
observational model: Cohort
time perspective: Prospective
measure: effect of different methods of feeding in the clinical condition of the acute severe pancreatitis
time frame: 13 days
description: first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis,The second pillar include effect of the two enteral feeding methods on the patient's tolerance
arm group label: Group A
description: Group A received nasogastric feeding (NG), insure through ngt pump
arm group label: Group B
description: receive feeding throughThe nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
Patients were placed in right lateral position
intervention type: Device
intervention name: nasogastric
description: • The insertion of NG tubes were performed by the ICU physician and the position was checked by auscultation of gas from 50 ml syringe by injecting 20 ml of air in the NG and by X-ray abdomen to be sure from the site of NG tube
arm group label: Group A
intervention type: Device
intervention name: nasojejunal
description: The nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
Patients were placed in right lateral position
arm group label: Group B
intervention type: Drug
intervention name: (erythromycin 250 mg IV bolus)
description: prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus
arm group label: Group A
arm group label: Group B
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Postoperative Nausea and Vomiting
mesh term: Erythromycin
mesh term: Erythromycin Estolate
mesh term: Erythromycin Ethylsuccinate
mesh term: Erythromycin stearate