Hepatic ComplicationPhase 1/2NCT03923816
Implication of Fluid Strategies Upon Hepatic Outcome in Hepatobiliary Surgery
A Phase 1/2 study testing Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR). in people with Hepatic Complication, run by Assiut University.
Trial summary
compare the effect of two different protocol of fluid therapy in patients undergoing elective hepatobiliary surgery under general anesthesia regarding hemodynamics and SGPT change pre- and postoperative. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Complication
- What is being tested?
- Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2021
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients>18 years old, undergoing elective hepatobiliary surgery under general anesthesia and American Society of Anesthesiologists grade II.
Who cannot join
- 1-patient refusal. 2-psychiatric disorders. 3-pregnancy and lactation. 4-preexisting neurological dysfunction (history of cerebrovascular stroke CVS) 5-metastatic cancer. 6-Inflammatory bowel disease. 7-Diabetes mellitus. 8-Renal insufficiency (serum creatinine level more than 180 μmol/l). 9- unexpected intraoperative findings (inoperable). 10-accidental massive intraoperative hemorrhage.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implications of Variable Intraoperative Fluid Strategies Upon the Hepatic Outcome in Hepatobiliary Surgery
compare the effect of two different protocol of fluid therapy in patients undergoing elective hepatobiliary surgery under general anesthesia regarding hemodynamics and SGPT change pre- and postoperative.
Read the detailed description
Fluid administration during and after surgery is an essential part of postoperative care to maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are associated with dehydration from preoperative fasting , bowel preparation, and intra- and postoperative fluid and electrolyte loss(1). So, perioperative fluid management has been a topic of much debate over years and has intensified especially over the past several years. The controversies include the type of fluid, the timing of administration and the volume administrated. Following much discussions and ongoing controversy on colloids versus crystalloids(2-5) and the ideal composition of the various intravenous solutions(6-8),the main focus more recently has been on the volume of fluids.
Fluid therapy strategies have been developed and implemented in clinical practice over several decades. The data suggest that aggressive or liberal intraoperative fluid resuscitation is harmful during open abdominal operation, whereas a restrictive fluid protocol has better outcomes, including fewer postoperative complications and a shorter discharge time. (9-11).
However , a restrictive fluid regimen has several limitations (12). Overly restricted or inadequate fluid administration may lead to insufficient intravascular volume, tissue hypoperfusion, cellular oxygenation impairment and potential organ dysfunction(13), prolonged recovery of bowel function, and impair tissue oxygenation, which might ultimately impair wound healing including healing of anastomosis.(14, 15) Recently, The Pleth variability index (PVI) derived from respiratory variations in peripheral perfusion index (PI) has been suggested to be an effective dynamic indicator of fluid responsiveness. Different from other invasive dynamic indices, PVI provides clinicians with a numerical value obtained noninvasively. (16-18) PVI is calculated as [(PImax - PImin)/PImax] X 100, where PImax and PImin represent the maximal and the minimal value, respectively, of the plethysmographic perfusion index (PI) over one respiratory cycle (16, 19). PI is the ratio between pulsatile and no pulsatile infrared light absorption from the pulse oximeter, and it is physiologically equivalent to the amplitude of the plethysmographic waveform (20). A PVI value of >13% before volume expansion discriminated between fluid responders and non-responders with 81% sensitivity and 100% specificity.
An extremely important feature of fluid therapy is ability to modulate inflammatory response in all its aspects with impact on a rate of neutrophil activation and modulation of cytokine and adhesive molecules expression. Isotonic sodium chloride solution and Ringer's lactate solution were shown to have pro-inflammatory properties while so called low volume therapy. Saline solution seems to be the most pro-inflammatory infusion fluid exerting negative impact on both macro- and microcirculation (21). Infusions of high volume of sodium chloride result in elevated serum chloride levels leading to acid-base imbalance and increase of free hydrogen ions (22).
Some available literature data show potential impact of Ringer's lactate therapy on induction of inflammatory response (23) but other reports do not support such phenomenon (24). Acetates similarly to lactates act as buffers and are easily broken down to bicarbonates. The difference between them is that lactates are metabolized mainly in the liver while acetates are metabolized in all body cells. The latter is especially beneficial in liver insufficiency, lactic acidosis and microcirculation insufficiency leading to organ hypoperfusion.
- Conditions
- Hepatic Complication
- Being tested
- Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).Drug
comparison of two intraoperative fluid strategies upon hepatic outcome in hepatobiliary surgery
| Study group | Role | What they receive |
|---|---|---|
| Group (R) | Experimental | Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR). Receives: Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR). |
| Group (C) | Experimental | Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR). Receives: Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
SGPT change pre- and postoperative
effects of different fluid strategies in change of SGBT level pre- and postoperative
Measured: preoperative and in the first and second day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Safwat, Assiut University
- Investigators
- Emad Zarief, assistant professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923816
- Sponsor's protocol ID
- fluids and hepatic outcome
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Variable Intraoperative Fluid Strategies Upon the Hepatic Outcome in Hepatobiliary Surgery
- ClinicalTrials.gov ID
- NCT03923816
- Acronym / sponsor ID
- fluids and hepatic outcome
- Conditions
- Hepatic Complication
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 23 Apr 2019 (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.
compare the effect of two different protocol of fluid therapy in patients undergoing elective hepatobiliary surgery under general anesthesia regarding hemodynamics and SGPT change pre- and postoperative.
Detailed description
Fluid administration during and after surgery is an essential part of postoperative care to maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are associated with dehydration from preoperative fasting , bowel preparation, and intra- and postoperative fluid and electrolyte loss(1). So, perioperative fluid management has been a topic of much debate over years and has intensified especially over the past several years. The controversies include the type of fluid, the timing of administration and the volume administrated. Following much discussions and ongoing controversy on colloids versus crystalloids(2-5) and the ideal composition of the various intravenous solutions(6-8),the main focus more recently has been on the volume of fluids.
Fluid therapy strategies have been developed and implemented in clinical practice over several decades. The data suggest that aggressive or liberal intraoperative fluid resuscitation is harmful during open abdominal operation, whereas a restrictive fluid protocol has better outcomes, including fewer postoperative complications and a shorter discharge time. (9-11).
However , a restrictive fluid regimen has several limitations (12). Overly restricted or inadequate fluid administration may lead to insufficient intravascular volume, tissue hypoperfusion, cellular oxygenation impairment and potential organ dysfunction(13), prolonged recovery of bowel function, and impair tissue oxygenation, which might ultimately impair wound healing including healing of anastomosis.(14, 15) Recently, The Pleth variability index (PVI) derived from respiratory variations in peripheral perfusion index (PI) has been suggested to be an effective dynamic indicator of fluid responsiveness. Different from other invasive dynamic indices, PVI provides clinicians with a numerical value obtained noninvasively. (16-18) PVI is calculated as [(PImax - PImin)/PImax] X 100, where PImax and PImin represent the maximal and the minimal value, respectively, of the plethysmographic perfusion index (PI) over one respiratory cycle (16, 19). PI is the ratio between pulsatile and no pulsatile infrared light absorption from the pulse oximeter, and it is physiologically equivalent to the amplitude of the plethysmographic waveform (20). A PVI value of >13% before volume expansion discriminated between fluid responders and non-responders with 81% sensitivity and 100% specificity.
An extremely important feature of fluid therapy is ability to modulate inflammatory response in all its aspects with impact on a rate of neutrophil activation and modulation of cytokine and adhesive molecules expression. Isotonic sodium chloride solution and Ringer's lactate solution were shown to have pro-inflammatory properties while so called low volume therapy. Saline solution seems to be the most pro-inflammatory infusion fluid exerting negative impact on both macro- and microcirculation (21). Infusions of high volume of sodium chloride result in elevated serum chloride levels leading to acid-base imbalance and increase of free hydrogen ions (22).
Some available literature data show potential impact of Ringer's lactate therapy on induction of inflammatory response (23) but other reports do not support such phenomenon (24). Acetates similarly to lactates act as buffers and are easily broken down to bicarbonates. The difference between them is that lactates are metabolized mainly in the liver while acetates are metabolized in all body cells. The latter is especially beneficial in liver insufficiency, lactic acidosis and microcirculation insufficiency leading to organ hypoperfusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (R) | Experimental | Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR). |
| Group (C) | Experimental | Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients>18 years old, undergoing elective hepatobiliary surgery under general anesthesia and American Society of Anesthesiologists grade II.
Key exclusion criteria (1 listed)
- 1-patient refusal. 2-psychiatric disorders. 3-pregnancy and lactation. 4-preexisting neurological dysfunction (history of cerebrovascular stroke CVS) 5-metastatic cancer. 6-Inflammatory bowel disease. 7-Diabetes mellitus. 8-Renal insufficiency (serum creatinine level more than 180 μmol/l). 9- unexpected intraoperative findings (inoperable). 10-accidental massive intraoperative hemorrhage.
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 |
|---|---|---|
| Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).comparison of two intraoperative fluid strategies upon hepatic outcome in hepatobiliary surgery | Drug | Group (C), Group (R) |
Primary outcome
SGPT change pre- and postoperative
Time frame: preoperative and in the first and second day postoperative
effects of different fluid strategies in change of SGBT level pre- and postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
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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.
Emad Zarief, assistant professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR). in people with Hepatic Complication, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Safwat (+201011237474, a.safwat1988@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SGPT change pre- and postoperative (time frame: preoperative and in the first and second day postoperative). 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 23 Apr 2019.