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

NCT ID: NCT03243526

Last Updated: 2019-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-20

Study Completion Date

2019-01-15

Brief Summary

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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

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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).

Conditions

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Lung; Congestive Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups one recieve fluid guided by CVP and othe by PPV
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
patient will be blinded and person who will do lung ultrasound

Study Groups

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Central venous pressure group

fluid therapy to maintain CVP not 5 cmH2o

Group Type PLACEBO_COMPARATOR

fluid therapy

Intervention Type OTHER

fluid resuscitation guided by CVP or PPV

Pulse pressure variation

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

Group Type EXPERIMENTAL

fluid therapy

Intervention Type OTHER

fluid resuscitation guided by CVP or PPV

Interventions

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fluid therapy

fluid resuscitation guided by CVP or PPV

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Elayashy Mohamed Ahmed Hassan

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Alainy Hospital , Faculty of Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 11003635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19338487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22546298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23936595 (View on PubMed)

Other Identifiers

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N-42-2017

Identifier Type: -

Identifier Source: org_study_id

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