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Clinical Trials/NCT03243526
NCT03243526CompletedNot Applicable

The Effect of Fluid Management Guided by Pulse Pressure Variation Versus Central Venous Pressure on Extra Vascular Lung Water Assessed by Lung Ultrasound Score During Liver Transplantation. A Randomized Controlled Trial.

Kasr El Aini Hospital1 site in 1 country40 target enrollmentStarted: August 20, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
lung ultrasound score

Study Overview

Brief Summary

the aim in this study to assess the effect of fluid management in patient undergoing orthotopic liver transplantation either by using pulse pressure variation or by central venous pressure. we will assess the impact of fluid management by either methods on oxygenation and extra vascular lung water visualized by lung ultrasound.

Detailed Description

After induction of anesthesia lung ultrasound will be performed and arterial blood gases (ABG) will be taken.

All patients in both groups will receive maintenance fluid in the form of crystalloids (ringer acetate) 4 ml/kg/H. Then fluid boluses will be given according to each group:

Group c (cvp): will receive 250 ml albumin 5% boluses to maintain CVP around 5 cmH2o Group P (ppv): will receive 250 ml albumin 5% boluses to maintain PPV below 13% as detected from invasive blood pressure monitor.

For all patients in both groups: blood transfusion will be indicated with decreased HB% level below 7 mg/dl in arterial blood gases. Other blood product (FFP, platelets and cryoprecipitate) transfusion will be guided by lab results and clinical status of patient. Plasma will be transfused if INR > 1.5 and platelets will be transfused if count < 50, 000

Lung ultrasound will be performed to diagnose EVLW. A Philips C5 ultrasound system (frequency 5Hz; Philips Medical Systems, Suresnes, France) with an ordinary echo probe will be used. Chest ultrasound will be performed using the 12 regions method. Intercostals spaces on each side will be examined anteriorly (midclavicular line), laterally (anterior axillary line) and posteriorly (posterior axillary line) Four ultrasound aeration patterns a. Normal aeration (N): 0 score ; line sliding sign associated with respiratory movement or less than 3 B lines ; b. Moderate loss of lung aeration: score 1 ; a clear number of multiple visible B-lines with horizontal spacing between adjacent B lines ≤ 7 mm (B7 lines) c. Severe loss of lung aeration: score 2; multiple B lines fused together that were difficult to count with horizontal spacing between adjacent B lines ≤ 3 mm (B3 lines); and d. Pulmonary consolidation: score 3; hyperechoic lung tissue, accompanied by dynamic air bronchogram.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Masking Description

patient will be blinded and person who will do lung ultrasound

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ASA physical status II- IV
  • Child C (end stage liver disease) ESLD patient.
  • Age (18- 70) years
  • Patients undergoing orthotopic liver transplantation.

Exclusion Criteria

  • Parents' refusal.
  • Patients with chronic pulmonary disease ( Asthma, obstructive lung disease or restrictive lung diseases)
  • Patient with impaired diastolic function more than grade I.

Outcomes

Primary Outcomes

lung ultrasound score

Time Frame: 5 minutes after surgical wound closure

lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36

Secondary Outcomes

  • P/F ratio(baseline 10 min after induction, 5 minutes after surgical wound closure and 1 hour after intensive care admission)
  • lung ultrasound score(baseline 10 minutes after induction. and 1 hour after Intensive care admission)

Investigators

Sponsor
Kasr El Aini Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Elayashy Mohamed Ahmed Hassan

clinical professor

Kasr El Aini Hospital

Study Sites (1)

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