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

Liver Transplantation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243526
• Other study ID #: N-42-2017
• Status: Completed
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: June 2019
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplantation
• Lung; Congestive

Intervention

Other:
• fluid therapy
fluid resuscitation guided by CVP or PPV

Locations

Country	Name	City	State
Egypt	Kasr Alainy Hospital , Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

Fallon MB, Abrams GA. Pulmonary dysfunction in chronic liver disease. Hepatology. 2000 Oct;32(4 Pt 1):859-65. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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