Elective Hepatic ResectionNCT01060683
Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
An observational study of Elective Hepatic Resection, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the accuracy of continuous SpHb measurement ( Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood sampling), both during phases of hemoconcentration and hemodilution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Hepatic Resection
- What is being tested?
- Hemoglobin determination + NaCl 0.9% bolus and hemoglobin determination + Venofundin bolus
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Jul 2011
- 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: ASA class I and II patients for elective hepatic resection
Who may be able to join
- All patients: Age > 18 years
- ASA class I and II patient requiring hepatic resection
Who cannot join
- Patient refusal
- Patients with a perioperative blood loss exceeding 5ml/kg
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen,University of Groningen, the Netherlands
Groningen, 9700RB
About this study
Official title: Liver Resection and Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
The purpose of this study is to evaluate the accuracy of continuous SpHb measurement ( Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood sampling), both during phases of hemoconcentration and hemodilution.
- Conditions
- Elective Hepatic Resection
- Being tested
- Hemoglobin determination + NaCl 0.9% bolus, hemoglobin determination + Venofundin bolus
- Keywords
- hemoglobin, Coagulation variables, blood chemistry, Blood gas analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin determination + NaCl 0.9% bolusBiological
hemoglobin determination + Venofundin bolusBiological
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 15 patients | for elective hepatic resection Receives: Biological: Hemoglobin determination + NaCl 0.9% bolus | |
| Group 2: 15 | for elective hepatic resection Receives: Biological: hemoglobin determination + Venofundin bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement
Measured: during operation
Secondary outcomes (1)
the effect of a bolus of crystalloid on SpHb level will be compared to the effect of a bolus of colloid on the SpHb level.
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Hepatic ResectionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herman G.D. Hendriks, Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060683
- Sponsor's protocol ID
- SpHb-001
- Status last verified
- Apr 2024
- First submitted
- 1 Feb 2010
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Vos JJ, Kalmar AF, Struys MM, Wietasch JK, Hendriks HG, Scheeren TW. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection. Br J Anaesth. 2013 Jun;110(6):940-6. doi: 10.1093/bja/aes508. Epub 2013 Jan 24.
PubMed 23348202
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Resection and Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
- ClinicalTrials.gov ID
- NCT01060683
- Acronym / sponsor ID
- SpHb-001
- Conditions
- Elective Hepatic Resection
- Keywords
- hemoglobin, Coagulation variables, blood chemistry, Blood gas analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Feb 2010 (estimated)
- 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.
The purpose of this study is to evaluate the accuracy of continuous SpHb measurement ( Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood sampling), both during phases of hemoconcentration and hemodilution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 15 patients | – | Biological: Hemoglobin determination + NaCl 0.9% bolusfor elective hepatic resection |
| Group 2: 15 | – | Biological: hemoglobin determination + Venofundin bolusfor elective hepatic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA class I and II patients for elective hepatic resection
Key inclusion criteria (2 listed)
- All patients: Age > 18 years
- ASA class I and II patient requiring hepatic resection
Key exclusion criteria (2 listed)
- Patient refusal
- Patients with a perioperative blood loss exceeding 5ml/kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemoglobin determination + NaCl 0.9% bolus | Biological | Group 1: 15 patients |
| hemoglobin determination + Venofundin bolus | Biological | Group 2: 15 |
Primary outcome
To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement
Time frame: during operation
1 secondary outcome
the effect of a bolus of crystalloid on SpHb level will be compared to the effect of a bolus of colloid on the SpHb level.
Time frame: during operation
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 18 Apr 2024.
- Derived from this study: PubMed 23348202Vos JJ, Kalmar AF, Struys MM, Wietasch JK, Hendriks HG, Scheeren TW. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection. Br J Anaesth. 2013 Jun;110(6):940-6. doi: 10.1093/bja/aes508. Epub 2013 Jan 24.
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.
Herman G.D. Hendriks, Dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Hepatic Resection, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 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 18 Apr 2024. 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 Netherlands. 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?
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?
To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement (time frame: during operation). 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 NCT01060683, which also lists 1 linked publication.
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 18 Apr 2024.