Indocyanine Clearance Rate and Septic Liver Injury

Prognostic Value of Indocyanine Clearance Rate for Sepsis Patients in ICU

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to SICU of our clinical center

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma clearance of indocyanine green	D0, D1, D2

Secondary Outcome Measures

Outcome Measure	Time Frame
Transaminase	D0, D1, D2, D4, D6
Bilirubin	D0, D1, D2, D4, D6
Prothrombin time	D0, D1, D2, D4, D6
Lactate	D0, D1, D2, D4, D6
γ-glutamyl transpeptidase	D0, D1, D2, D4, D6
Cholinesterase	D0, D1, D2, D4, D6

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Rank N, Michel C, Haertel C, Lenhart A, Welte M, Meier-Hellmann A, Spies C. N-acetylcysteine increases liver blood flow and improves liver function in septic shock patients: results of a prospective, randomized, double-blind study. Crit Care Med. 2000 Dec;28(12):3799-807. doi: 10.1097/00003246-200012000-00006.
• Sakka SG, Reinhart K, Meier-Hellmann A. Does the optimization of cardiac output by fluid loading increase splanchnic blood flow? Br J Anaesth. 2001 May;86(5):657-62. doi: 10.1093/bja/86.5.657.
• Poeze M, Ramsay G, Buurman WA, Greve JW, Dentener M, Takala J. Increased hepatosplanchnic inflammation precedes the development of organ dysfunction after elective high-risk surgery. Shock. 2002 Jun;17(6):451-8. doi: 10.1097/00024382-200206000-00002.
• Mizushima Y, Tohira H, Mizobata Y, Matsuoka T, Yokota J. Assessment of effective hepatic blood flow in critically ill patients by noninvasive pulse dye-densitometry. Surg Today. 2003;33(2):101-5. doi: 10.1007/s005950300021.
• Inal MT, Memis D, Kargi M, Sut N. Prognostic value of indocyanine green elimination assessed with LiMON in septic patients. J Crit Care. 2009 Sep;24(3):329-34. doi: 10.1016/j.jcrc.2008.11.012. Epub 2009 Feb 12.
• Kopterides P, Siempos II, Tsangaris I, Tsantes A, Armaganidis A. Procalcitonin-guided algorithms of antibiotic therapy in the intensive care unit: a systematic review and meta-analysis of randomized controlled trials. Crit Care Med. 2010 Nov;38(11):2229-41. doi: 10.1097/CCM.0b013e3181f17bf9.
• Kortgen A, Paxian M, Werth M, Recknagel P, Rauchfuss F, Lupp A, Krenn CG, Muller D, Claus RA, Reinhart K, Settmacher U, Bauer M. Prospective assessment of hepatic function and mechanisms of dysfunction in the critically ill. Shock. 2009 Oct;32(4):358-65. doi: 10.1097/SHK.0b013e31819d8204.
• Slotman GJ, Fisher CJ Jr, Bone RC, Clemmer TP, Metz CA. Detrimental effects of high-dose methylprednisolone sodium succinate on serum concentrations of hepatic and renal function indicators in severe sepsis and septic shock. The Methylprednisolone Severe Sepsis Study Group. Crit Care Med. 1993 Feb;21(2):191-5. doi: 10.1097/00003246-199302000-00008.
• Seibel A, Sakka SG. [Indocyanine green plasma disappearance rate: estimation of abdominal perfusion disturbances]. Anaesthesist. 2010 Dec;59(12):1091-8. doi: 10.1007/s00101-010-1754-2. Epub 2010 Aug 18. German.
• Mathes AM, Kubulus D, Weiler J, Bentley A, Waibel L, Wolf B, Bauer I, Rensing H. Melatonin receptors mediate improvements of liver function but not of hepatic perfusion and integrity after hemorrhagic shock in rats. Crit Care Med. 2008 Jan;36(1):24-9. doi: 10.1097/01.CCM.0000292088.33318.F0.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: October 4, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Estimate): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: liver injury; sepsis; indocyanine green; abdominal perfusion pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: SLICG; 2011180 (Other Identifier: The First Affiliated Hospital, Sun Yat-sen University)