Fluid OverloadNCT03429751
Ultrasound Lung Fluid Responsiveness During Hysterectomy
A study testing 30 ml/Kg/h crystalloid and 10 ml/Kg/h crystalloid in people with Fluid Overload, run by Alaa Mazy at 1 site in Egypt.
Trial summary
Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fluid Overload
- What is being tested?
- 30 ml/Kg/h crystalloid and 10 ml/Kg/h crystalloid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2016to 1 Sep 2017
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients scheduled for an elective laparoscopic hysterectomy.
- American society of anesthesiologists status I-II.
Who cannot join
- Patient refusal.
- Severe cardiac insufficiency (New York Heart Association IV, myocardial infarction 3 months).
- Valvular heart diseases.
- Renal insufficiency (GFR<60 ml/kg/1.73m2).
- Hepatic insufficiency (Albumin less than 3).
- Patient with previous or current history of pulmonary disease.
- History of allergy to anesthetic drugs.
- Obese patients (BMI>30).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oncology Center Mansoura University.
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Ultrasound Lung Evaluation of Different Fluid Management Protocols in Patients Undergoing Laparoscopic Hysterectomy.
Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific evidence on optimal intraoperative fluid management has resulted in large variations of administered fluid regimens in daily practice. The restricted perioperative intravenous fluid regimen reduces complications after elective surgeries, however other studies had shown that intraoperative liberal fluid administration improves postoperative organ functions and recovery and shortens hospital stay after elective surgeries.
Read the detailed description
A review of patients undergoing major abdominal surgery, excluding high-risk patients, compared liberal and restrictive fluid regimens; concluded that it is difficult to define 'liberal' or 'restrictive' protocols in clinical practice. patients undergoing moderate-risk surgery seem to benefit from the more liberal fluid administration, while patients undergoing high-risk or major surgery seem to benefit from restrictive or conservative strategies. Lung ultrasound used for comparison between liberal and restrictive fluid therapy in laparoscopic hysterectomy patients by detecting the B-lines intraoperatively or immediately postoperatively. The aim is to evaluate the lung ultrasound as a guide for intraoperative fluid management, being an index for increased extravascular lung water (ECLW). This operation is a moderately complex procedure that implies the Trendelenburg position. This position - in addition to liberal fluids - will increase venous return and increase the challenge on the cardiac muscle under anesthesia in these patients.
- Conditions
- Fluid Overload
- Being tested
- 30 ml/Kg/h crystalloid, 10 ml/Kg/h crystalloid
- Keywords
- lung ultrasound, fluid, hysterectomy, B lines
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 ml/Kg/h crystalloidDrug
Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 30 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.
10 ml/Kg/h crystalloidDrug
Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 10 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Liberal fluid group | Experimental | received 30 ml/Kg/h crystalloid for maximum 3 hours. Receives: Drug: 30 ml/Kg/h crystalloid |
| Restrictive fluid group | Active comparator | received 10 ml /Kg/h crystalloids for maximum 3 hours. Receives: Drug: 10 ml/Kg/h crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of lung ultrasound B lines appearance.
Three or more comet lines appearance in a lung field. Two or more positive regions per side suggested a B-pattern. B -lines are defined as discrete laser-like vertical hyper-echoic artifacts that arise from the pleura line extend to the bottom of the screen without fading and move synchronously with lung sliding.
Measured: 5 minutes after the end of surgery.
Secondary outcomes (14)
The total volume of crystalloid infusion.
milliliter
Measured: Intraoperative.
The total volume of blood transfusion.
milliliter
Measured: Intraoperative.
The amount of blood loss.
milliliter, estimated from the weight of swaps and suction bottles.
Measured: Intraoperative.
The duration of surgery.
minutes. from the time of induction of anesthesia till extubation time.
Measured: intraoperative.
Central venous pressure
centimeter water.
Measured: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Mean blood pressure
millimeter mercury.
Measured: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Heart rate.
Beats per minute.
Measured: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Peripheral oxygen saturation.
percent.
Measured: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Hourly urine output.
milliliter,
Measured: intraoperative,
Arterial blood gases.
for arterial oxygen and carbon dioxide tensions in millimeter mercury, base excess level in millimole per liter.
Measured: 15 minutes preoperative, 15 minutes postoperative.
Serum sodium level.
millimole per liter.
Measured: 15 minutes preoperative, 15 minutes postoperative.
Serum potassium level.
millimole per liter.
Measured: 15 minutes preoperative, 15 minutes postoperative.
Hemoglobin level.
milligram per deciliter.
Measured: 15 minutes preoperative, 15 minutes postoperative.
Hematocrit value.
percent.
Measured: 15 minutes preoperative, 15 minutes postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start10 Jul 2016
- Primary completion10 Jul 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Mazy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Mazy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429751
- Sponsor's protocol ID
- MS/16.06.76
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Lung Evaluation of Different Fluid Management Protocols in Patients Undergoing Laparoscopic Hysterectomy.
- ClinicalTrials.gov ID
- NCT03429751
- Acronym / sponsor ID
- MS/16.06.76
- Conditions
- Fluid Overload
- Keywords
- lung ultrasound, fluid, hysterectomy, B lines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alaa MazyUniversity, hospital or other
- Study start
- 10 Jul 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 12 Feb 2018 (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.
Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific evidence on optimal intraoperative fluid management has resulted in large variations of administered fluid regimens in daily practice. The restricted perioperative intravenous fluid regimen reduces complications after elective surgeries, however other studies had shown that intraoperative liberal fluid administration improves postoperative organ functions and recovery and shortens hospital stay after elective surgeries.
Detailed description
A review of patients undergoing major abdominal surgery, excluding high-risk patients, compared liberal and restrictive fluid regimens; concluded that it is difficult to define 'liberal' or 'restrictive' protocols in clinical practice. patients undergoing moderate-risk surgery seem to benefit from the more liberal fluid administration, while patients undergoing high-risk or major surgery seem to benefit from restrictive or conservative strategies. Lung ultrasound used for comparison between liberal and restrictive fluid therapy in laparoscopic hysterectomy patients by detecting the B-lines intraoperatively or immediately postoperatively. The aim is to evaluate the lung ultrasound as a guide for intraoperative fluid management, being an index for increased extravascular lung water (ECLW). This operation is a moderately complex procedure that implies the Trendelenburg position. This position - in addition to liberal fluids - will increase venous return and increase the challenge on the cardiac muscle under anesthesia in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal fluid group | Experimental | Drug: 30 ml/Kg/h crystalloidreceived 30 ml/Kg/h crystalloid for maximum 3 hours. |
| Restrictive fluid group | Active comparator | Drug: 10 ml/Kg/h crystalloidreceived 10 ml /Kg/h crystalloids for maximum 3 hours. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female patients scheduled for an elective laparoscopic hysterectomy.
- American society of anesthesiologists status I-II.
Key exclusion criteria (8 listed)
- Patient refusal.
- Severe cardiac insufficiency (New York Heart Association IV, myocardial infarction 3 months).
- Valvular heart diseases.
- Renal insufficiency (GFR<60 ml/kg/1.73m2).
- Hepatic insufficiency (Albumin less than 3).
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 |
|---|---|---|
| 30 ml/Kg/h crystalloidLung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 30 ml/Kg/h crystalloid in addition to losses for maximum 3 hours. | Drug | Liberal fluid group |
| 10 ml/Kg/h crystalloidLung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 10 ml/Kg/h crystalloid in addition to losses for maximum 3 hours. | Drug | Restrictive fluid group |
Primary outcome
The rate of lung ultrasound B lines appearance.
Time frame: 5 minutes after the end of surgery.
Three or more comet lines appearance in a lung field. Two or more positive regions per side suggested a B-pattern. B -lines are defined as discrete laser-like vertical hyper-echoic artifacts that arise from the pleura line extend to the bottom of the screen without fading and move synchronously with lung sliding.
14 secondary outcomes
The total volume of crystalloid infusion.
Time frame: Intraoperative.
The total volume of blood transfusion.
Time frame: Intraoperative.
The amount of blood loss.
Time frame: Intraoperative.
The duration of surgery.
Time frame: intraoperative.
Central venous pressure
Time frame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Mean blood pressure
Time frame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Heart rate.
Time frame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Peripheral oxygen saturation.
Time frame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Hourly urine output.
Time frame: intraoperative,
Arterial blood gases.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Serum sodium level.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Serum potassium level.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Hemoglobin level.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Hematocrit value.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
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 12 Feb 2018.
- 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 30 ml/Kg/h crystalloid and 10 ml/Kg/h crystalloid in people with Fluid Overload, run by Alaa Mazy 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 2 inclusion and 8 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 12 Feb 2018. 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. 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?
The rate of lung ultrasound B lines appearance. (time frame: 5 minutes after the end of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.