Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05349292
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2022-04-21
Brief Title:
Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Effect of Low-volume Fluid Replacement Strategy During Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels an Acute Kidney Injury Biomarker
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute normovolemic hemodilution ANH is performed as a blood conservation technique during surgical procedures with high risk for significant blood loss It is done by taking out some of the patients blood before surgery actually begins and storing this blood inside of the operating room and giving it back to the patient at the end of surgery when most of the expected surgical bleeding has already occurred This practice reduces the amount of bleeding that occurs after surgery and also reduces the amount of blood transfusions given to the patient after surgery Transfusion of blood products from the blood bank may cause problems such as transfusion reactions and infections like hepatitis and also increases cost
3 meta-analyses and several smaller trials have shown improvement in blood transfusion rates with the use of ANH however there is no evidence of improvement in other complication rates morbidity and mortality length of stay or cost
In most types of surgery when ANH is done large volumes of IV fluids are given to the patient to prevent a drop in circulatory volume and blood pressure However during heart surgery this can cause significant levels of hemodilution in addition to that caused by use of the heart-lung machine In order to minimize hemodilution when ANH is performed during heart surgery a smaller amount of IV fluids are given to the patient after blood is drawn Vasoactive medications are then administered to prevent the blood pressure from dropping
Kidney injury is a recognized complication that may occur after heart surgery It may be caused by low blood volume low blood pressure and anemia It is not known whether performance of ANH and use of the heart-lung machine may increase risk for kidney injury Kidney injury is associated with increased risk for other medical complications and death This increased risk for kidney injury arising from ANH has not been evaluated This study will therefore compare patients treated with ANH to those not treated with ANH to determine whether there is an increased risk for kidney injury with the use of ANH
3 meta-analyses and several smaller trials have shown improvement in blood transfusion rates with the use of ANH however there is no evidence of improvement in other complication rates morbidity and mortality length of stay or cost
In most types of surgery when ANH is done large volumes of IV fluids are given to the patient to prevent a drop in circulatory volume and blood pressure However during heart surgery this can cause significant levels of hemodilution in addition to that caused by use of the heart-lung machine In order to minimize hemodilution when ANH is performed during heart surgery a smaller amount of IV fluids are given to the patient after blood is drawn Vasoactive medications are then administered to prevent the blood pressure from dropping
Kidney injury is a recognized complication that may occur after heart surgery It may be caused by low blood volume low blood pressure and anemia It is not known whether performance of ANH and use of the heart-lung machine may increase risk for kidney injury Kidney injury is associated with increased risk for other medical complications and death This increased risk for kidney injury arising from ANH has not been evaluated This study will therefore compare patients treated with ANH to those not treated with ANH to determine whether there is an increased risk for kidney injury with the use of ANH
Detailed Description:
The study population will consist of 50 adult patients less than 70 years old undergoing elective coronary artery bypass graft CABG surgery with anticipated CPB duration less than 2 hours at the University of Maryland Medical Center UMMC Patients less than 70kg in weight and patients with renal insufficiency andor hemoglobin levels less than 12gdL will be excluded We shall also exclude patients with heart failure EF 40 and any significant hepatic or pulmonary comorbidities including pulmonary hypertension Patients undergoing emergency and redo cardiac surgery and those with inherited or acquired bleeding disorders will also be excluded
This study will be a non-blinded randomized prospective observational study Due to the nature of the intervention being evaluated blinding will not be achievable We shall randomly divide patients into 2 groups where one group will be managed with ANH and the other without control group Patients managed with ANH will have 12cckg of blood salvaged and stored at room temperature prior to CPB The stored blood will then be administered to the patient after CPB Intravascular volume will be replenished in a 11 ratio with balanced crystalloid solution during blood salvage The other group of patients will receive an empiric 7cckg bolus of intravenous balanced crystalloid solution prior to CPB On average crystalloid infusions are limited to about 500cc prior to CPB to minimize hemodilution of blood
Patients will otherwise be managed according to normal protocols and pathways used in the perioperative management of CS patients at UMMC
This study will be a non-blinded randomized prospective observational study Due to the nature of the intervention being evaluated blinding will not be achievable We shall randomly divide patients into 2 groups where one group will be managed with ANH and the other without control group Patients managed with ANH will have 12cckg of blood salvaged and stored at room temperature prior to CPB The stored blood will then be administered to the patient after CPB Intravascular volume will be replenished in a 11 ratio with balanced crystalloid solution during blood salvage The other group of patients will receive an empiric 7cckg bolus of intravenous balanced crystalloid solution prior to CPB On average crystalloid infusions are limited to about 500cc prior to CPB to minimize hemodilution of blood
Patients will otherwise be managed according to normal protocols and pathways used in the perioperative management of CS patients at UMMC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None