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Indocyanine Clearance Rate and Septic Liver Injury

NCT ID: NCT01447836

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis

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

No interventions assigned to this group

Control

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Guanqing Sun

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guanxiang Dong, MD, PhD

Role: STUDY_CHAIR

Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University

Guanqing Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University

Locations

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Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guanqing Sun

Role: CONTACT

[email protected]
+86-15602380755

Facility Contacts

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Guanqing Sun, MD

Role: primary

[email protected]
+86-15602380755

References

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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.

Reference Type BACKGROUND
PMID: 11153617 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11575341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12069179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12616369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19327336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20729729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19197231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8428468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20714702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18090374 (View on PubMed)

Other Identifiers

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2011180

Identifier Type: OTHER

Identifier Source: secondary_id

SLICG

Identifier Type: -

Identifier Source: org_study_id