NCT01447836

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

October 4, 2011

Last Update Submit

October 5, 2011

Conditions

Sepsis

Keywords

indocyanine greensepsisliver injuryabdominal perfusion pressure

Outcome Measures

Primary Outcomes (1)

  • Plasma clearance of indocyanine green

    D0, D1, D2

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to SICU of our clinical center

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 11153617BACKGROUND

  • 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.

    PMID: 11575341BACKGROUND

  • 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.

    PMID: 12069179BACKGROUND

  • 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.

    PMID: 12616369BACKGROUND

  • 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.

    PMID: 19327336BACKGROUND

  • 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.

    PMID: 20729729BACKGROUND

  • 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.

    PMID: 19197231BACKGROUND

  • 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.

    PMID: 8428468BACKGROUND

  • 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.

    PMID: 20714702BACKGROUND

  • 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.

    PMID: 18090374BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guanxiang Dong, MD, PhD

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

    STUDY CHAIR

  • Guanqing Sun, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guanqing Sun

CONTACT

+86-15602380755speczhl@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 6, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2012

Study Completion

November 1, 2012

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

CN(1)