Indocyanine Clearance Rate and Septic Liver Injury

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01447836
Collaborator
(none)
100
1
16.1
6.2

Study Details

Study Description

Brief Summary

Liver injury is a complication of sepsis and septic liver injury has adverse impact upon the outcome. As a measurement for liver function, Plasma clearance rate of indocyanine green (PDR-ICG) always decreased during the early phase of sepsis. So the investigators hypotheses include: PDR-ICG is lower in sepsis patients than non-septic patients in ICU; PDR-ICG may be lower in abdominal sepsis patients than non-abdominal sepsis patients in ICU; PDR-ICG correlates with abdominal perfusion pressure; change of PDR-ICG in early phase correlates with change of transaminase or bilirubin in late phase of sepsis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Liver injury is a complication of sepsis and septic liver injury has adverse impact upon the outcome. However, changes of transaminase or bilirubin are always not significant during the early phase of sepsis. As another sort of measurement of liver function, plasma clearance rate of indocyanine green (PDR-ICG) always decreased during the early phase of sepsis. So the investigators hypotheses include: PDR-ICG may be lower in sepsis patients than non-septic patients in ICU; PDR-ICG may be lower in abdominal sepsis patients than non-abdominal sepsis patients in ICU; PDR-ICG correlates with abdominal perfusion pressure; change of PDR-ICG in early phase may correlate with change of transaminase or bilirubin in late phase of sepsis. Through this study we also plan to calculate the range of abdominal perfusion pressure that can maintain normal PDR-ICG and the range of PDR-ICG that can maintain normal transaminase or bilirubin level in sepsis patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prognostic Value of Indocyanine Clearance Rate for Sepsis Patients in ICU
    Study Start Date :
    Jul 1, 2011
    Anticipated Primary Completion Date :
    Aug 1, 2012
    Anticipated Study Completion Date :
    Nov 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Sepsis

    Sepsis patients who are admitted to SICU of our clinical center.

    Control

    Postoperative patients who underwent abdominal surgery and then was directly transferred to SICU of our clinical center.

    Outcome Measures

    Primary Outcome Measures

    1. Plasma clearance of indocyanine green [D0, D1, D2]

    Secondary Outcome Measures

    1. Transaminase [D0, D1, D2, D4, D6]

    2. Bilirubin [D0, D1, D2, D4, D6]

    3. Prothrombin time [D0, D1, D2, D4, D6]

    4. Lactate [D0, D1, D2, D4, D6]

    5. γ-glutamyl transpeptidase [D0, D1, D2, D4, D6]

    6. Cholinesterase [D0, D1, D2, D4, D6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • For control group: the patient does not match the diagnosis criteria of sepsis before the operation; the operation was done in peritoneal cavity; the patient is transferred to SICU directly from surgical room or recovery room; the patient is anticipated to stay in SICU for more than 48 hours.

    • For study group: the patient matches the diagnosis criteria of sepsis; the patient is anticipated to stay in SICU for more than 48 hours.

    Exclusion Criteria:
    • Pregnancy

    • Age < 18 years

    • The infection is purely caused by virus

    • Obstruction of biliary tract, or acute cholangitis, or acute liver abscess, or active hepatitis, or hyperacute/acute liver rejection occurs during study period

    • Hemorrhagic shock occurs during study period

    • Asthma occurs during study period

    • Acute coronary syndrome occurs during study period

    • Continuing peripheral circulation dysfunction leads to refractory "low quality" during PDR-ICG measurement

    • Comorbidity of the bladder leads to impossibility to measure intra-abdominal pressure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Study Chair: Guanxiang Dong, MD, PhD, Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University
    • Principal Investigator: Guanqing Sun, MD, Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Guanqing Sun, Resident doctor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT01447836
    Other Study ID Numbers:
    • SLICG
    • 2011180
    First Posted:
    Oct 6, 2011
    Last Update Posted:
    Oct 6, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Guanqing Sun, Resident doctor, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2011