Indocyanine GreenIGHINCT04570800
One Way to Diagnose Hepatic Insufficiency the First Postoperative Day After Resection: Prospective Cohort Study
An observational study of Indocyanine Green and Postoperative Complications, run by Castilla-La Mancha Health Service.
Trial summary
Introduction: Hepatic insufficiency is a complication that puts the life of the patient undergoing resective surgery at risk. Thus, the diagnosis should be made early. The current gold standard allows its diagnosis on the fifth postoperative day. Indocyanine green is a water soluble dye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indocyanine Green, Postoperative Complications, Acute Liver Failure
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Mar 2017
- How long will I take part?
- 6 Months
- 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: Surgical patients scheduled for liver surgery, who agreed to be included in the study and signed the informed consent given to them following information given about the aims of the study and its possible complications, were included in the study consecutively for a period of two years
Who may be able to join
- Patients susceptible of receiving Surgical treatment
- Liver Disease with Surgical Indication
- Adulthood
- Accept Inclusion
Who cannot join
- History of Hypersensitivity to Indocyanine Green or Iodine
- Thyroid Pathology
- Underage Status
- Pregnant
- Irresectable Tumors
About this study
Introduction: Hepatic insufficiency is a complication that puts the life of the patient undergoing resective surgery at risk. Thus, the diagnosis should be made early. The current gold standard allows its diagnosis on the fifth postoperative day.
Indocyanine green is a water soluble dye. When administered intravenously, it binds to plasma proteins and it is removed unchanged by bile, without experiencing enterohepatic recirculation, which allows estimating the function of hepatocytes and the function of hepato-splacnic flow. There is a measurement system named "Non-invasive liver function monitor" (LiMON®, PULSION Medical Systems, Munich, Germany), which allows the measurement of indocyanine green clearance at the patient's bedside.
Read more
Justification: The use of indocyanine green plasma disappearance during the perioperative period tries to know the exact value of the hepatic function in the most real conditions, when the excision has been performed, thus giving the investigators the actual value of the unresected liver. This allows te investigators to estimate the risk of hepatic insufficiency development that can lead to hepatic failure. Due to the characteristics of the test, it could get reliable results earlier than the current "gold standard " (50:50 Criteria on the 5th postoperative day).
Hypotheses and Objectives: The investigators hypothesized that the determination of the hepatic reserve by identifying the indocyanine plasma clearance in real time after hepatic parenchymal resection could lead to a more accurate and earlier statement of the hepatic reserve than current tests.
The aim of the study is to determine the usefulness of indocyanine green in the perioperative period to early diagnosis of hepatic failure.
Materials and Methods: A prospective observational post-authorization study (EPA-SP) is performed to study de usefulness of indocyanine green. The study was approved by the Ethics and Clinical Research Committee of the University General Hospital of Ciudad Real. Surgical patients scheduled for liver surgery, who agreed to be included in the study and signed an informed consent, were included in the study over a two-year period, after having understood the study objectives and its possible complications.
Measurements were performed with the LiMON® monitor prior to liver resection and on the first postoperative day to patients undergoing liver resection surgery and compared with gold standard.
- Keywords
- Indocyanine green, LIMON, Postoperative liver failure
- Medical subject headings
- Postoperative Complications, Liver Failure, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 5th postoperative day
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 5th postoperative day
Measured: 5 days
Secondary outcomes (1)
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 3th postoperative day
Number of patients the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 3th postoperative day
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study startDec 2014
- Primary completionJun 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indocyanine GreenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 44 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570800
- Sponsor's protocol ID
- VBG-IND-2014-01
- Acronym
- IGHI
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Way to Diagnose Hepatic Insufficiency the First Postoperative Day After Resection: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04570800
- Acronym / sponsor ID
- IGHI / VBG-IND-2014-01
- Keywords
- Indocyanine green, LIMON, Postoperative liver failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Hepatic insufficiency is a complication that puts the life of the patient undergoing resective surgery at risk. Thus, the diagnosis should be made early. The current gold standard allows its diagnosis on the fifth postoperative day.
Indocyanine green is a water soluble dye. When administered intravenously, it binds to plasma proteins and it is removed unchanged by bile, without experiencing enterohepatic recirculation, which allows estimating the function of hepatocytes and the function of hepato-splacnic flow. There is a measurement system named "Non-invasive liver function monitor" (LiMON®, PULSION Medical Systems, Munich, Germany), which allows the measurement of indocyanine green clearance at the patient's bedside.
Justification: The use of indocyanine green plasma disappearance during the perioperative period tries to know the exact value of the hepatic function in the most real conditions, when the excision has been performed, thus giving the investigators the actual value of the unresected liver. This allows te investigators to estimate the risk of hepatic insufficiency development that can lead to hepatic failure. Due to the characteristics of the test, it could get reliable results earlier than the current "gold standard " (50:50 Criteria on the 5th postoperative day).
Hypotheses and Objectives: The investigators hypothesized that the determination of the hepatic reserve by identifying the indocyanine plasma clearance in real time after hepatic parenchymal resection could lead to a more accurate and earlier statement of the hepatic reserve than current tests.
The aim of the study is to determine the usefulness of indocyanine green in the perioperative period to early diagnosis of hepatic failure.
Materials and Methods: A prospective observational post-authorization study (EPA-SP) is performed to study de usefulness of indocyanine green. The study was approved by the Ethics and Clinical Research Committee of the University General Hospital of Ciudad Real. Surgical patients scheduled for liver surgery, who agreed to be included in the study and signed an informed consent, were included in the study over a two-year period, after having understood the study objectives and its possible complications.
Measurements were performed with the LiMON® monitor prior to liver resection and on the first postoperative day to patients undergoing liver resection surgery and compared with gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients scheduled for liver surgery, who agreed to be included in the study and signed the informed consent given to them following information given about the aims of the study and its possible complications, were included in the study consecutively for a period of two years
Key inclusion criteria (4 listed)
- Patients susceptible of receiving Surgical treatment
- Liver Disease with Surgical Indication
- Adulthood
- Accept Inclusion
Key exclusion criteria (5 listed)
- History of Hypersensitivity to Indocyanine Green or Iodine
- Thyroid Pathology
- Underage Status
- Pregnant
- Irresectable Tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 5th postoperative day
Time frame: 5 days
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 5th postoperative day
1 secondary outcome
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 3th postoperative day
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Indocyanine Green and Postoperative Complications, run by Castilla-La Mancha Health Service.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 5th postoperative day (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2020.