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

NCT03243526 | Completed

• 1 other identifier: N-42-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Congestive; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• lung ultrasound score

  baseline 10 minutes after induction. and 1 hour after Intensive care admission

• P/F ratio

  baseline 10 min after induction, 5 minutes after surgical wound closure and 1 hour after intensive care admission

Study Arms (2)

Central venous pressure group

PLACEBO COMPARATOR

fluid therapy to maintain CVP not 5 cmH2o

Other: fluid therapy

Pulse pressure variation

EXPERIMENTAL

fluid therapy will be guided by PPV to be less than 14%

Other: fluid therapy

Interventions

fluid therapy OTHER

fluid resuscitation guided by CVP or PPV

Central venous pressure group; Pulse pressure variation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospital , Faculty of Medicine

Cairo, Egypt

Location

Related Publications (4)

• 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.

  PMID: 11003635 BACKGROUND

• 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.

  PMID: 19338487 BACKGROUND

• 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.

  PMID: 22546298 BACKGROUND

• 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.

  PMID: 23936595 BACKGROUND

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patient will be blinded and person who will do lung ultrasound
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: two groups one recieve fluid guided by CVP and othe by PPV

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 9, 2017
• Study Start: August 20, 2017
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

EG (1)