Indocyanine Clearance Rate and Septic Liver Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Guanqing Sun, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01447836
First received: October 4, 2011
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Indocyanine Clearance Rate for Sepsis Patients in ICU

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Plasma clearance of indocyanine green [ Time Frame: D0, D1, D2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Transaminase [ Time Frame: D0, D1, D2, D4, D6 ] [ Designated as safety issue: Yes ]
  • Bilirubin [ Time Frame: D0, D1, D2, D4, D6 ] [ Designated as safety issue: Yes ]
  • Prothrombin time [ Time Frame: D0, D1, D2, D4, D6 ] [ Designated as safety issue: Yes ]
  • Lactate [ Time Frame: D0, D1, D2, D4, D6 ] [ Designated as safety issue: Yes ]
  • γ-glutamyl transpeptidase [ Time Frame: D0, D1, D2, D4, D6 ] [ Designated as safety issue: Yes ]
  • Cholinesterase [ Time Frame: D0, D1, D2, D4, D6 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood for transaminase, hemoglobin, prothrombin time, lactate and oxygen pressure test.


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to SICU of our clinical center

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447836

Contacts
Contact: Guanqing Sun +86-15602380755 speczhl@hotmail.com

Locations
China, Guangdong
Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Guanqing Sun, MD    +86-15602380755    speczhl@hotmail.com   
Principal Investigator: Guanqing Sun, MD         
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
  More Information

Publications:

Responsible Party: Guanqing Sun, Resident doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01447836     History of Changes
Other Study ID Numbers: SLICG, 2011180
Study First Received: October 4, 2011
Last Updated: October 5, 2011
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
indocyanine green
sepsis
liver injury
abdominal perfusion pressure

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014