Pre Bypass Ultrafiltration (PBUF) in Children Requiring Cardiopulmonary Bypass

NCT03576534 | Terminated

• 1 other identifier: P00028603
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Newborn babies and children with congenital heart defects who need heart surgery need to be placed on the heart-lung machine for heart surgery. In order to use the heart-lung machine, the investigators have to use blood and other fluids to fill the tubing. During the operation, ultrafiltration is carried out as standard of care to remove extra fluid. Modified ultrafiltration is also performed after surgery. In this study, the investigators are looking to use the filter additionally before surgery. Using the pre bypass filtration before the subject is placed on the heart-lung machine will allow the investigators to better normalize electrolytes in the blood/fluid mixture used in the heart lung machine. This technique is called pre-bypass ultrafiltration, or PBUF (pronounced "P" Buff). The investigators are conducting a study to see if using PBUF to better normalize electrolytes in the blood will make a difference. The investigators have been adding fluids to prime the heart-lung machine in two different ways. The investigators believe both methods are safe and acceptable but hypothesize that there may be subtle differences in electrolytes and fluid status when one technique is used as opposed to the other. The investigators believe that neither technique introduces risk since both are currently used in practice. The standard method adds blood to the heart-lung machine. The alternate method adds blood to the heart-lung machine and then additional fluid is added and removed to more normalize the electrolytes. The investigators plan to randomized subjects undergoing heart surgery to receive the standard priming method versus PBUF to determine if there is any difference in outcomes. Laboratory and clinical data collected as part of clinical care will be used to determine difference sin outcomes. There will be no additional blood taken for this study. There are no known risks to PBUF. The benefits include helping investigators determine if PBUF does or does not make a difference to how subjects recover after surgery. The investigators believe that providing more normal blood values will either improve the subjects' outcome or have no benefit. The investigators do not anticipate increased risks. Given COVID -19 restrictions, the study is on hold.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (4)

• Glucose in milligrams per deciliter (mg/dL). Normal range 61 to 199 mg/dL

  Differences in glucose (mg/dl) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU

  12 hours

• Sodium in milliequivalents per liter (mEq/L). Normal range 135 to 148 mEq/L

  Differences in sodium (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU

  12 hours

• Potassium in milliequivalents per liter (mEq/L). Normal range 3.2 to 4.5 mEg/L

  Differences in potassium (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU

  12 hours

• Lactate in milliequivalents per liter (mEq/L). Normal range 0.5 to 2.2 mEq/L

  Differences in lactate (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU

  12 hours

Secondary Outcomes (11)

• Osmolality in milli osmoles per kilogram (mOsm/Kg). Normal Range 276- 295 mOsm/kg

  12 hours

• Plasma free hemoglobin in milligrams per deciliter (mg/dL). Normal < 5 mg/dL.

  12 hours

• Inotrope use

  72 hours

• Body wall edema as measured daily weights in kilograms (Kg)

  Through study completion (until hospital discharge), an average of 15 days.

• Body wall edema as measured daily weights in kilograms (Kg)

  Through study completion (until hospital discharge) , an average of 15 days.

Study Arms (2)

Control

NO INTERVENTION

Standard of care

Study

ACTIVE COMPARATOR

PBUF used prior to Cardiopulmonary bypass

Other: Use of prebypass ultrafiltration (PBUF)

Interventions

Use of prebypass ultrafiltration (PBUF) OTHER

In addition to standard of care for cardiopulmonary bypass, in the study arm prebypass ultrafiltration will be performed.

Study

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients \< 8 kilograms and \< 1 year (to ensure that all patients receive steroids at initiation of CPB) undergoing an index cardiac operation for that hospitalization (using a single PBUF protocol)

You may not qualify if:

• Patients undergoing repeat cardiac surgery within the same admission
• Patients undergoing transplants as their index surgery
• Patients undergoing Ventricular assist device implantation as their index surgery

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (16)

• Moore GL, Peck CC, Sohmer PR, Zuck TF. Some properties of blood stored in anticoagulant CPDA-1 solution. A brief summary. Transfusion. 1981 Mar-Apr;21(2):135-7. doi: 10.1046/j.1537-2995.1981.21281178147.x.

  PMID: 7222197 BACKGROUND

• de Vroege R, Wildevuur WR, Muradin JA, Graves D, van Oeveren W. Washing of stored red blood cells by an autotransfusion device before transfusion. Vox Sang. 2007 Feb;92(2):130-5. doi: 10.1111/j.1423-0410.2006.00852.x.

  PMID: 17298575 BACKGROUND

• Hall TL, Barnes A, Miller JR, Bethencourt DM, Nestor L. Neonatal mortality following transfusion of red cells with high plasma potassium levels. Transfusion. 1993 Jul;33(7):606-9. doi: 10.1046/j.1537-2995.1993.33793325059.x.

  PMID: 8333025 BACKGROUND

• Baz EM, Kanazi GE, Mahfouz RA, Obeid MY. An unusual case of hyperkalaemia-induced cardiac arrest in a paediatric patient during transfusion of a 'fresh' 6-day-old blood unit. Transfus Med. 2002 Dec;12(6):383-6. doi: 10.1046/j.1365-3148.2002.00402.x.

  PMID: 12473156 BACKGROUND

• O'Leary MF, Szklarski P, Klein TM, Young PP. Hemolysis of red blood cells after cell washing with different automated technologies: clinical implications in a neonatal cardiac surgery population. Transfusion. 2011 May;51(5):955-60. doi: 10.1111/j.1537-2995.2010.02935.x. Epub 2010 Nov 23.

  PMID: 21091957 BACKGROUND

• Masalunga C, Cruz M, Porter B, Roseff S, Chui B, Mainali E. Increased hemolysis from saline pre-washing RBCs or centrifugal pumps in neonatal ECMO. J Perinatol. 2007 Jun;27(6):380-4. doi: 10.1038/sj.jp.7211748. Epub 2007 Apr 19.

  PMID: 17443201 BACKGROUND

• Rao R, Georgieff MK. Iron in fetal and neonatal nutrition. Semin Fetal Neonatal Med. 2007 Feb;12(1):54-63. doi: 10.1016/j.siny.2006.10.007. Epub 2006 Dec 6.

  PMID: 17157088 BACKGROUND

• Mumby S, Chaturvedi RR, Brierley J, Lincoln C, Petros A, Redington AN, Gutteridge JM. Iron overload in paediatrics undergoing cardiopulmonary bypass. Biochim Biophys Acta. 2000 Mar 17;1500(3):342-8. doi: 10.1016/s0925-4439(00)00003-x.

  PMID: 10699376 BACKGROUND

• Jeffers A, Gladwin MT, Kim-Shapiro DB. Computation of plasma hemoglobin nitric oxide scavenging in hemolytic anemias. Free Radic Biol Med. 2006 Nov 15;41(10):1557-65. doi: 10.1016/j.freeradbiomed.2006.08.017. Epub 2006 Aug 25.

  PMID: 17045924 BACKGROUND

• Vercaemst L. Hemolysis in cardiac surgery patients undergoing cardiopulmonary bypass: a review in search of a treatment algorithm. J Extra Corpor Technol. 2008 Dec;40(4):257-67.

  PMID: 19192755 BACKGROUND

• Messent M, Sinclair DG, Quinlan GJ, Mumby SE, Gutteridge JM, Evans TW. Pulmonary vascular permeability after cardiopulmonary bypass and its relationship to oxidative stress. Crit Care Med. 1997 Mar;25(3):425-9. doi: 10.1097/00003246-199703000-00009.

  PMID: 9118657 BACKGROUND

• Hackbarth RM, Eding D, Gianoli Smith C, Koch A, Sanfilippo DJ, Bunchman TE. Zero balance ultrafiltration (Z-BUF) in blood-primed CRRT circuits achieves electrolyte and acid-base homeostasis prior to patient connection. Pediatr Nephrol. 2005 Sep;20(9):1328-33. doi: 10.1007/s00467-005-1970-1. Epub 2005 Jun 10.

  PMID: 15947984 BACKGROUND

• Delaney M, Axdorff-Dickey RL, Crockett GI, Falconer AL, Levario MJ, McMullan DM. Risk of extracorporeal life support circuit-related hyperkalemia is reduced by prebypass ultrafiltration. Pediatr Crit Care Med. 2013 Jul;14(6):e263-7. doi: 10.1097/PCC.0b013e31828a70c5.

  PMID: 23823207 BACKGROUND

• Nagashima M, Imai Y, Seo K, Terada M, Aoki M, Shinoka T, Koide M. Effect of hemofiltrated whole blood pump priming on hemodynamics and respiratory function after the arterial switch operation in neonates. Ann Thorac Surg. 2000 Dec;70(6):1901-6. doi: 10.1016/s0003-4975(00)02024-5.

  PMID: 11156092 BACKGROUND

• Grist G. Boiling the frog: the dangers of elevated sodium in blood primed pumps for infants. AmSECT Today.2012;Nov/Dec:5.

  BACKGROUND

• Matte GS. Perfusion for Congenital Heart Surgery: Notes on Cardiopulmonary Bypass for a Complex Patient Population. Oxford: Wiley-Blackwell; 2015. Chapter 2, Page 27-32.

  BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Meena Nathan, MD, MPH

  Boston Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon, Department of Cardiac Surgery

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: July 3, 2018
• Study Start: October 3, 2019
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)