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Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart Surgery

Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart Surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016101130266N1
Enrollment
70
Registered
2017-08-26
Start date
2016-12-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular heart disease. Nonrheumatic mitral valve disorders, Nonrheumatic aortic valve disorders, Nonrheumatic tricuspid valve disorders, Pulmonary valve disorders

Interventions

Intervention 1: During open heart surgery when patient is on cardiopulmonary bypass after aortic cross clamping and cardioplegic arrest patients undergoing pulsatile perfusion. pulsatile features on h
During open heart surgery when patient is on cardiopulmonary bypass after aortic cross clamping and cardioplegic arrest patients undergoing pulsatile perfusion. pulsatile features on heart lung machi
In control group during cardiopulmonary bypass after aortic cross clamping patients undergoing routine(non pulsatile) perfusion.

Sponsors

Vice Chancellor Of Research, Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with valvular heart disease that needs surgical replacement or repair of heart valves, body surface area less than 2, Age 18 to 65, Estimated cardiopulmonary bypass time greater than 60 minute, Left ventricle ejection fraction(LVEF) 40% and greater than 40% Exclusion criteria: patients with carotid stenosis, atherosclerosis of ascending aorta and aortic arch, history of cerebrovascular accident, diabetic patient, hepatic disorders, alcoholism, patients needs emergency or complicated and redo surgeries, congenital heart disease, pregnancy, patients disagreement(without consent), preoperation arterial lactate levels greater than 2 miliigram per deciliter, arteial blood gases not in normal rang during cardiopulmonary bypass, patients who needs intraaortic baloon pump(IABP), extracorporeal membrane oxygenation(ECMO) or patients with open sternum, cardiac arrest

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Arterial blood lactate level. Timepoint: after anasthasia and mechanical ventilation, after aortic cross clamping, after aortic cross clamp removal, termination of cardiopulmonary bypass, 2 and 4 hours post operation room. Method of measurement: arterial blood sample ( our lab reference unit is milligram per decilitre).;Cerebral oxygenetion. Timepoint: During the whole time of surgery and cardiopulmonary bypass. Method of measurement: To evaluate cerebral oxygenetion we use INVOS cerebral /somatic oxymeter, the values are measured continuously as a percentage of oxygen saturation.

Secondary

MeasureTime frame
Liver enzymes(AST& ALT). Timepoint: Pre & Post operation. Method of measurement: blood sample(our lab reference unit is Unit per liter).;Renal function tests( BUN & Cr). Timepoint: Pre & Post operation. Method of measurement: blood sample(our lab reference unit is milligram per deciliter).;Lactate dehydrogenase(LDH). Timepoint: Pre & Post operation. Method of measurement: blood sample( our lab reference unit is Unit per liter).;Platelet count. Timepoint: Pre & Post operation. Method of measurement: blood sample(our lab reference unit is platelete count per microliters).;Urine out put. Timepoint: Pre CPB, Pre aortic cross clamp, after removal of aortic cross clamp, termination of CPB. Method of measurement: Through direct vision urine volume(in millilite)r is measured by collecting in urine bag.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamira Moosaei Far

Iran University of Medical Sciences

samira.moosaei@gmail.commosaeifar.s@tak.iums.ac.ir+98 919 165 0136

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026