Clinical trial NCT01447836: Indocyanine Clearance Rate and Septic Liver Injury
Official title: Prognostic Value of Indocyanine Clearance Rate for Sepsis Patients in ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: indocyanine green
sepsis
liver injury
abdominal perfusion pressure
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to SICU of our clinical center

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma clearance of indocyanine green
timeFrame: D0, D1, D2
Secondary outcomes:
measure: Transaminase
timeFrame: D0, D1, D2, D4, D6
measure: Bilirubin
timeFrame: D0, D1, D2, D4, D6
measure: Prothrombin time
timeFrame: D0, D1, D2, D4, D6
measure: Lactate
timeFrame: D0, D1, D2, D4, D6
measure: γ-glutamyl transpeptidase
timeFrame: D0, D1, D2, D4, D6
measure: Cholinesterase
timeFrame: D0, D1, D2, D4, D6
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University
name: Guanxiang Dong, MD, PhD
role: STUDY_CHAIR
affiliation: Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University
name: Guanqing Sun, MD
role: PRINCIPAL_INVESTIGATOR
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