| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatic Complication | Drug: Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR). | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Implications of Variable Intraoperative Fluid Strategies Upon the Hepatic Outcome in Hepatobiliary Surgery |
| Estimated Study Start Date : | October 1, 2019 |
| Estimated Primary Completion Date : | October 1, 2020 |
| Estimated Study Completion Date : | October 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group (R)
Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
|
Drug: 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
|
|
Experimental: Group (C)
Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).
|
Drug: 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
|
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Ahmed Safwat | +201011237474 | a.safwat1988@gmail.com | |
| Contact: Emad Zarief | +201007046058 | emadzarief@yahoo.com |
| Study Director: | Emad Zarief, assistant professor | Assiut University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 18, 2019 | ||||||||
| First Posted Date ICMJE | April 23, 2019 | ||||||||
| Last Update Posted Date | April 23, 2019 | ||||||||
| Estimated Study Start Date ICMJE | October 1, 2019 | ||||||||
| Estimated Primary Completion Date | October 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Implication of Fluid Strategies Upon Hepatic Outcome in Hepatobiliary Surgery | ||||||||
| Official Title ICMJE | Implications of Variable Intraoperative Fluid Strategies Upon the Hepatic Outcome in Hepatobiliary Surgery | ||||||||
| Brief 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. | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE | Hepatic Complication | ||||||||
| Intervention ICMJE | Drug: 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
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
100 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 1, 2021 | ||||||||
| Estimated Primary Completion Date | October 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03923816 | ||||||||
| Other Study ID Numbers ICMJE | fluids and hepatic outcome | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Ahmed Safwat, Assiut University | ||||||||
| Study Sponsor ICMJE | Assiut University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Assiut University | ||||||||
| Verification Date | April 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||