Continuous Hemoglobin Monitoring in Pediatric Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958984
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : December 18, 2014
Information provided by (Responsible Party):
James Sullivan, MD, University of Nebraska

Brief 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. Hemoglobin values reflect oxygen-carrying capacity of the blood and PVI reflects fluid balance and perfusion.

Condition or disease
Pediatric Solid Organ Transplant

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 Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Hemoglobin and Plethysmograph Variability Index Monitoring May Provide Superior Assessment During Visceral Solid Organ Transplantation in Children: a Prospective Cohort Study
Study Start Date : August 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : November 2011

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients under age 19 years of age undergoing visceral solid organ transplant at The Nebraska Medical Center

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • prospective subjects already under the effects of anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958984

United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Principal Investigator: James Sullivan, MD University of Nebraska

Responsible Party: James Sullivan, MD, Principal Investigator, University of Nebraska Identifier: NCT00958984     History of Changes
Other Study ID Numbers: 294-09-FB
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by James Sullivan, MD, University of Nebraska:
solid organ transplant