Pediatric Solid Organ TransplantNCT00958984
Continuous Hemoglobin Monitoring in Pediatric Transplant
An observational study of Pediatric Solid Organ Transplant, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical utility of non-invasive monitoring of Hemoglobin (Hgb) and Plethysmograph Variability Index (PVI) values during the intraoperative period of visceral solid organ transplantation in children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Solid Organ Transplant
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2009to 1 Nov 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under age 19 years of age undergoing visceral solid organ transplant at The Nebraska Medical Center
Who may be able to join
- age between birth up to, and including, 18 years
- undergoing solid organ transplantation at The Nebraska Medical Center
- signed informed consent and assent as applicable
Who cannot join
- prospective subjects already under the effects of anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68105
About this study
Official title: Continuous Hemoglobin and Plethysmograph Variability Index Monitoring May Provide Superior Assessment During Visceral Solid Organ Transplantation in Children: a Prospective Cohort Study
The purpose of this study is to determine the clinical utility of non-invasive monitoring of Hemoglobin (Hgb) and Plethysmograph Variability Index (PVI) values during the intraoperative period of visceral solid organ transplantation in children. Hemoglobin values reflect oxygen-carrying capacity of the blood and PVI reflects fluid balance and perfusion.
Read the detailed description
Background and Significance: The pediatric visceral solid organ transplant patient experiences significant hemodynamic changes and anemia during the process of transplantation. These changes occur as a result of several factors: 1) Concomitant high output cardiac failure found with liver failure causes an increased sensitivity to modest decreases in intravascular volume resulting in hypotension and shock; 2) Patients may experience significant blood loss [2 to 6 times circulating blood volume] during the operative period; 3) Replenishment of intravascular volume based on intermittent hgb measurements, estimates of blood loss and hemodynamic insufficiency leads to prolongation of anemia and/or development of polycythemia. Continuous monitoring of hgb and PVI should prove superior to current procedure to determine intravascular volume depletion, anemia and prevent polycythemia. Based on the findings of this study, an intraoperative treatment algorithm can be developed for the efficacious and judicious use of blood products and fluids during resuscitation and improved perioperative management of the pediatric transplant patient.
Specific Aims: 1) Determine the severity, time of onset, and duration of PVI variability consistent with hypovolemia in relation to organ explantation, vascular clamping, reperfusion of newly transplanted organ(s) and bleeding events. 2) Determine the severity, time of onset, and duration of anemia (hgb < 8 gm/dL) and polycythemia (hgb > 13 gm/dL) in relation to these events. 3) Determine if the administration of blood products, crystalloid, and colloid solutions based on subjective assessment of hemodynamic indices, blood loss and intermittent hemoglobin measurement leads to inappropriate intraoperative resuscitation .
Preliminary Data: Episodic hemoglobin sampling during transplantation in 13 pediatric patients at NMC revealed the following: anemic values occurred in 69% (9/13) of the patients, with 38% (5/13) of those having 3 or more anemic values (lowest hgb: 1.7g/dL); polycythemic values occurred in 13% (2/13) of the patients (highest hgb: 14.8g/ dL). All patients displayed hypotension during the operative period despite having CVP measurements that matched pre-transplant values. During a recent introductory session for the Masimo Rainbow SET monitor and sensor probe, a toddler undergoing liver, small bowel, and pancreas transplant was observed and hemoglobin values were noted from both the Masimo monitor and conventional episodic blood sampling. Values obtained from both sources simultaneously revealed ≤ 1 g/dL discrepancy between the measurement methods in 100% of the values.
Research Protocol: Twenty-one subjects ≤18 years of age undergoing solid organ transplant, will be monitored during the intraoperative period transcutaneously for continuous PVI and hgb. Data collection will also include continuous CVP and MAP, significant operative events, concurrent blood loss, fluid administration, and conventional episodic Hgb sampling. Data from the hospital monitoring system will be time synchronized with Masimo derived measurements. The research team will coordinate recording of all events in the intra-operative period using standardized case report forms. Anesthesiologist and transplant team are blinded to Masimo data. Continuous Hgb and PVI will not be used to determine clinical treatment. The expected duration of this study will be two years based on the average number of pediatric solid organ transplant procedures participated in by the Anesthesiology Department at The Nebraska Medical Center.
- Conditions
- Pediatric Solid Organ Transplant
- Keywords
- pediatric, solid organ transplant, hemoglobin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study start11 Aug 2009
- Primary completion1 Aug 2011
- Study completion1 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid Organ TransplantStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Sullivan, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958984
- Sponsor's protocol ID
- 0294-09-FB
- Status last verified
- Aug 2023
- First submitted
- 13 Aug 2009
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Hemoglobin and Plethysmograph Variability Index Monitoring May Provide Superior Assessment During Visceral Solid Organ Transplantation in Children: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT00958984
- Acronym / sponsor ID
- 0294-09-FB
- Conditions
- Pediatric Solid Organ Transplant
- Keywords
- pediatric, solid organ transplant, hemoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 11 Aug 2009 (actual)
- Primary completion
- 1 Aug 2011 (actual)
- Study completion
- 1 Nov 2011 (actual)
- First posted
- 14 Aug 2009 (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 determine the clinical utility of non-invasive monitoring of Hemoglobin (Hgb) and Plethysmograph Variability Index (PVI) values during the intraoperative period of visceral solid organ transplantation in children. Hemoglobin values reflect oxygen-carrying capacity of the blood and PVI reflects fluid balance and perfusion.
Detailed description
Background and Significance: The pediatric visceral solid organ transplant patient experiences significant hemodynamic changes and anemia during the process of transplantation. These changes occur as a result of several factors: 1) Concomitant high output cardiac failure found with liver failure causes an increased sensitivity to modest decreases in intravascular volume resulting in hypotension and shock; 2) Patients may experience significant blood loss [2 to 6 times circulating blood volume] during the operative period; 3) Replenishment of intravascular volume based on intermittent hgb measurements, estimates of blood loss and hemodynamic insufficiency leads to prolongation of anemia and/or development of polycythemia. Continuous monitoring of hgb and PVI should prove superior to current procedure to determine intravascular volume depletion, anemia and prevent polycythemia. Based on the findings of this study, an intraoperative treatment algorithm can be developed for the efficacious and judicious use of blood products and fluids during resuscitation and improved perioperative management of the pediatric transplant patient.
Specific Aims: 1) Determine the severity, time of onset, and duration of PVI variability consistent with hypovolemia in relation to organ explantation, vascular clamping, reperfusion of newly transplanted organ(s) and bleeding events. 2) Determine the severity, time of onset, and duration of anemia (hgb < 8 gm/dL) and polycythemia (hgb > 13 gm/dL) in relation to these events. 3) Determine if the administration of blood products, crystalloid, and colloid solutions based on subjective assessment of hemodynamic indices, blood loss and intermittent hemoglobin measurement leads to inappropriate intraoperative resuscitation .
Preliminary Data: Episodic hemoglobin sampling during transplantation in 13 pediatric patients at NMC revealed the following: anemic values occurred in 69% (9/13) of the patients, with 38% (5/13) of those having 3 or more anemic values (lowest hgb: 1.7g/dL); polycythemic values occurred in 13% (2/13) of the patients (highest hgb: 14.8g/ dL). All patients displayed hypotension during the operative period despite having CVP measurements that matched pre-transplant values. During a recent introductory session for the Masimo Rainbow SET monitor and sensor probe, a toddler undergoing liver, small bowel, and pancreas transplant was observed and hemoglobin values were noted from both the Masimo monitor and conventional episodic blood sampling. Values obtained from both sources simultaneously revealed ≤ 1 g/dL discrepancy between the measurement methods in 100% of the values.
Research Protocol: Twenty-one subjects ≤18 years of age undergoing solid organ transplant, will be monitored during the intraoperative period transcutaneously for continuous PVI and hgb. Data collection will also include continuous CVP and MAP, significant operative events, concurrent blood loss, fluid administration, and conventional episodic Hgb sampling. Data from the hospital monitoring system will be time synchronized with Masimo derived measurements. The research team will coordinate recording of all events in the intra-operative period using standardized case report forms. Anesthesiologist and transplant team are blinded to Masimo data. Continuous Hgb and PVI will not be used to determine clinical treatment. The expected duration of this study will be two years based on the average number of pediatric solid organ transplant procedures participated in by the Anesthesiology Department at The Nebraska Medical Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under age 19 years of age undergoing visceral solid organ transplant at The Nebraska Medical Center
Key inclusion criteria (3 listed)
- age between birth up to, and including, 18 years
- undergoing solid organ transplantation at The Nebraska Medical Center
- signed informed consent and assent as applicable
Key exclusion criteria (1 listed)
- prospective subjects already under the effects of anesthesia
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
Not reported in the source record.
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 6 Sep 2023.
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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.
James Sullivan, MD principal investigator
University of Nebraska
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 Pediatric Solid Organ Transplant, run by University of Nebraska at 1 site in United States.
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 3 inclusion and 1 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 6 Sep 2023. 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 United States. 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.
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 6 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.