Lung; CongestiveNCT03243526
Effect of Fluid Management Guided by Pulse Pressure Variation Vs Central Venous Pressure on Lung Water Assessed by Lung Ultrasound During Liver Transplantation
A study testing fluid therapy in people with Lung; Congestive and Liver Transplantation, run by Kasr El Aini Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung; Congestive, Liver Transplantation
- What is being tested?
- fluid therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2017to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status II- IV
- Child C (end stage liver disease) ESLD patient.
- Age (18- 70) years
- Patients undergoing orthotopic liver transplantation.
Who cannot join
- Parents' refusal.
- Patients with chronic pulmonary disease ( Asthma, obstructive lung disease or restrictive lung diseases)
- Patient with impaired diastolic function more than grade I.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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).
- Conditions
- Lung; Congestive, Liver Transplantation
- Being tested
- fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid therapyOther
fluid resuscitation guided by CVP or PPV
| Study group | Role | What they receive |
|---|---|---|
| Central venous pressure group | Placebo comparator | fluid therapy to maintain CVP not 5 cmH2o Receives: Other: fluid therapy |
| Pulse pressure variation | Experimental | fluid therapy will be guided by PPV to be less than 14% Receives: Other: fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound score
lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36
Measured: 5 minutes after surgical wound closure
Secondary outcomes (2)
lung ultrasound score
lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36
Measured: baseline 10 minutes after induction. and 1 hour after Intensive care admission
P/F ratio
ratio of Po2 to fraction of inspired oxygen.
Measured: baseline 10 min after induction, 5 minutes after surgical wound closure and 1 hour after intensive care admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start20 Aug 2017
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung; CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups one recieve fluid guided by CVP and othe by PPV
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elayashy Mohamed Ahmed Hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243526
- Sponsor's protocol ID
- N-42-2017
- Status last verified
- Jun 2019
- First submitted
- 27 Jul 2017
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 11003635Bozbas 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.
PubMed 19338487Gardelli 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.
PubMed 22546298Aghdashi 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.
PubMed 23936595
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03243526
- Acronym / sponsor ID
- N-42-2017
- Conditions
- Lung; Congestive, Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The final LUS of the patient was the sum of each regional ultrasound score (ranging from 0 to 36).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups one recieve fluid guided by CVP and othe by PPV
| Arm | Type | Receives |
|---|---|---|
| Central venous pressure group | Placebo comparator | Other: fluid therapyfluid therapy to maintain CVP not 5 cmH2o |
| Pulse pressure variation | Experimental | Other: fluid therapyfluid therapy will be guided by PPV to be less than 14% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status II- IV
- Child C (end stage liver disease) ESLD patient.
- Age (18- 70) years
- Patients undergoing orthotopic liver transplantation.
Key exclusion criteria (3 listed)
- Parents' refusal.
- Patients with chronic pulmonary disease ( Asthma, obstructive lung disease or restrictive lung diseases)
- Patient with impaired diastolic function more than grade I.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluid therapyfluid resuscitation guided by CVP or PPV | Other | Central venous pressure group, Pulse pressure variation |
Primary outcome
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
2 secondary outcomes
lung ultrasound score
Time frame: baseline 10 minutes after induction. and 1 hour after Intensive care admission
P/F ratio
Time frame: baseline 10 min after induction, 5 minutes after surgical wound closure and 1 hour after intensive care admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Background: PubMed 11003635Fallon 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.
- Background: PubMed 19338487Bozbas 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.
- Background: PubMed 22546298Gardelli 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.
- Background: PubMed 23936595Aghdashi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluid therapy in people with Lung; Congestive and Liver Transplantation, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung ultrasound score (time frame: 5 minutes after surgical wound closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03243526, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.