Effect of Fluid Management Guided by Pulse Pressure Variation Vs Central Venous Pressure on Lung Water Assessed by Lung Ultrasound During Liver Transplantation

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.

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Lung; Congestive
• Intervention / Treatment: Other: fluid therapy

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.

The final LUS of the patient was the sum of each regional ultrasound score (ranging from 0 to 36).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alainy Hospital , Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Central venous pressure group; fluid therapy to maintain CVP not 5 cmH2o	Other: fluid therapy; fluid resuscitation guided by CVP or PPV
Experimental: Pulse pressure variation; fluid therapy will be guided by PPV to be less than 14%	Other: fluid therapy; fluid resuscitation guided by CVP or PPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung ultrasound score	lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36	5 minutes after surgical wound closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung ultrasound score	lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36	baseline 10 minutes after induction. and 1 hour after Intensive care admission
P/F ratio	ratio of Po2 to fraction of inspired oxygen.	baseline 10 min after induction, 5 minutes after surgical wound closure and 1 hour after intensive care admission

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General Publications

• Fallon MB, Abrams GA. Pulmonary dysfunction in chronic liver disease. Hepatology. 2000 Oct;32(4 Pt 1):859-65. doi: 10.1053/jhep.2000.7519. No abstract available.
• Bozbas SS, Eyuboglu FO, Ozturk Ergur F, Gullu Arslan N, Sevmis S, Karakayali H, Haberal M. Pulmonary complications and mortality after liver transplant. Exp Clin Transplant. 2008 Dec;6(4):264-70.
• Gardelli G, Feletti F, Nanni A, Mughetti M, Piraccini A, Zompatori M. Chest ultrasonography in the ICU. Respir Care. 2012 May;57(5):773-81. doi: 10.4187/respcare.01743.
• Aghdashi M, Broofeh B, Mohammadi A. Diagnostic performances of high resolution trans-thoracic lung ultrasonography in pulmonary alveoli-interstitial involvement of rheumatoid lung disease. Int J Clin Exp Med. 2013 Aug 1;6(7):562-6. Print 2013.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N-42-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No