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SepsisNCT01447836

Indocyanine Clearance Rate and Septic Liver Injury

An observational study of Sepsis, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
How many people
100 participants
Where
1 siteChina
Study dates
Jul 2011to Nov 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to SICU of our clinical center

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Guanqing Sun contact

+86-15602380755

speczhl@hotmail.com

China1 site, 1 recruiting

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

    Guangzhou, Guangdong, 510080

    Guanqing Sun, MD, +86-15602380755, speczhl@hotmail.com

    Guanqing Sun, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Sepsis
Keywords
indocyanine green, sepsis, liver injury, abdominal perfusion pressure
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01447836
Study groupRoleWhat they receive
SepsisSepsis patients who are admitted to SICU of our clinical center.
ControlPostoperative patients who underwent abdominal surgery and then was directly transferred to SICU of our clinical center.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma clearance of indocyanine green

    Measured: D0, D1, D2

Secondary outcomes (6)

  1. Transaminase

    Measured: D0, D1, D2, D4, D6

  2. Bilirubin

    Measured: D0, D1, D2, D4, D6

  3. Prothrombin time

    Measured: D0, D1, D2, D4, D6

  4. Lactate

    Measured: D0, D1, D2, D4, D6

  5. γ-glutamyl transpeptidase

    Measured: D0, D1, D2, D4, D6

  6. Cholinesterase

    Measured: D0, D1, D2, D4, D6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionAug 2012 (estimated)
  4. Study completionNov 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01447836
Sponsor's protocol ID
SLICG
Other IDs
2011180
Status last verified
Oct 2011
First submitted
4 Oct 2011
Last updated
6 Oct 2011
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 11153617

  • 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.

    PubMed 11575341

  • 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.

    PubMed 12069179

  • 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.

    PubMed 12616369

  • 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.

    PubMed 19327336

  • 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.

    PubMed 20729729

  • 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.

    PubMed 19197231

  • 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.

    PubMed 8428468

  • 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.

    PubMed 20714702

  • 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.

    PubMed 18090374

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guanqing Sun (+86-15602380755, speczhl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma clearance of indocyanine green (time frame: D0, D1, D2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01447836, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2011.

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