ObesityNCT04855318
Fluid Replacement in Bariatric Surgery
An observational study of Obesity, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The frequency of obese postoperative rhabdomyolized acute tubular necrosis (ATN) and renal failure is also increasing. It is simply important to manage fluid. The fluid requirement should be higher than planned. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 20 Mar 2021
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 64 years
- All sexes
- Adult
Study population: sample size 60
Who may be able to join
- obese patients who scheduled for elective bariatric surgery
Who cannot join
- severe cardiac arrhythmia
- peripheral artery disease
- an ejection fraction <30%
- any pulmonary pathology preventing a respiratory volume >6 ml/kg/min on mechanical ventilation
- hepatic or renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Plethysmographic Variability Index Monitoring on Fluid Replacement in Bariatric Surgery
The frequency of obese postoperative rhabdomyolized acute tubular necrosis (ATN) and renal failure is also increasing. It is simply important to manage fluid. The fluid requirement should be higher than planned. In order to learn the postoperative ATN and the development of renal failure, 4-5 lt crystalloid fluid should be given in 2-3 times or 1.5 ml / kg / h should be provided in the upper outlet.
According to TVA, there are no good guidelines for intraoperative fluid management in bariatric surgery. Different intraoperative fluid management communications are used. The key to improving outcomes from post-operative treatment is "patient directed fluid management" or "targeted fluid management". The use of Perioperative Goal-Directed Fluid Therapy Technologies helps the anesthesiologist closely monitor the patient and strike the delicate balance between benefit and risk. Plethysmographic variability index monitoring (PVI-Pleth Variability Index) is a non-invasive, automatic and continuous monitor that displays patient fluid response, it is one of the easily applicable and easily interpreted monitoring methods. With PVI monitoring, intraoperative hypotension and fluid need can be predicted in advance.
Plethysmographic Variability Index (PVI) is the determination of the importance of monitoring of intraoperative volume replacement and its effect on postoperative operations.
Read the detailed description
Obesity is defined as an increase in body weight beyond requirements as a result of excessive fat accumulation in the body and is common Obesity leads to an increase in health problems and morbidity and mortality, as well as individual and social problems and a decrease in the workforce. Despite sports, diet, lifestyle changes and medical treatments, the rate of obesity continues to increase in the population. The most effective and durable treatment option for morbid obesity is bariatric surgery. Video laparoscopic bariatric surgery (VLBS) is recognized as the best surgical technique for morbidly obese individuals with health complications associated with excess body fat. Despite the proven benefits of VLBS, it can model a systemic inflammatory response. VLBS also poses an inherent risk of pneumoperitoneum for the kidneys due to high intra-abdominal pressure, which reduces cortical capillary blood flow by increasing renal vascular resistance. As a result, the glomerular filtration rate (GFR) decreases and transient oliguria occurs. Acute renal failure manifested as a large increase in creatinine levels with oliguria.
It is a preventable complication with intraoperative anesthesia management.Glomerular filtration rate (GFR) and increased renal plasma flow cause hyperfiltration syndrome in obesity. Adinopectin, proinflammatory cytokines, oxidative stress and pharmacological nephrotoxicity are the mechanisms affecting acute kidney injury in obesity. Chronic renal failure occurs as a result of a decrease in albiminuria and GFR. They are the causes of postoperative renal failure in patients with diabetes, a history of kidney disease, using antihypertensive drugs containing diuretics, and obese patients with a BMI greater than 50 kg / m2, prolonged operation time, and intraoperative hypotension.
The frequency of acute tubular necrosis (ATN) and renal failure due to postoperative rhabdomyolysis is also increased in obese patients. Fluid management is important to prevent this. The fluid requirement should be higher than planned. In order to prevent the development of postoperative ATN and renal failure, 4-5 liters of crystalloid fluid should be given in 2-3 hours or urine output above 1.5 ml / kg / h should be provided.
According to TVA, there are studies performing crystalloid fluid replacement in a wide range of 15-40 ml / kg.
In obese patients, changes in distribution volume such as decreased hepatic blood flow, increase in renal blood flow and glomerular filtration rate and increase in the amount of free-flowing drug are the most important factors affecting the pharmacokinetics of drugs. Drug doses used in these patients are recommended to be calculated according to total body weight (TVA), ideal body weight (IVA), and lean body weight (HVA = IVA + 20%), taking into account the lipophilic nature of the drug. For example in induction; when using high lipophilic drugs according to YVA or IVA; moderately lipophilic For drugs, the dosage can be increased by 20-40% and used according to the YVA.Propofol's high lipophilic properties cause its effect to start very quickly and to be short-lived. It has been shown in many studies that there is no usable accumulation or prolongation of propofol compared to TVA in obese patients.
Short-acting remifentanil, one of the lipophilic synthetic opioids, can be administered according to IVA .
There are no well-known guidelines for intraoperative fluid management in bariatric surgery. Different intraoperative fluid management protocols are used. The key to improving outcomes from treatment in the post-operative period is "patient directed fluid management" or "targeted fluid management". The use of Perioperative Goal-Directed Fluid Therapy Technologies helps the anesthesiologist to closely monitor the patient and establish the delicate balance between benefit and risk. Plethysmographic variability index monitoring (PVI-Pleth Variability Index) is a non-invasive, automatic and continuous monitor that displays the fluid response of patients, and is one of the easy-to-apply and easily interpreted monitoring methods. It has been shown that intraoperative hypotension and fluid need can be predicted with PVI monitoring.
The aim of this study is to determine the effect of Pleth Variability Index (PVI) monitoring on intraoperative volume replacement amount and postoperative complications in obese patients who underwent bariatric surgery.
Patients and Methods
Patients A total of 60 obese patients who scheduled for elective bariatric surgery were included in this single-blind prospective randomized study. Patients were required to have an ASA physical status class 2 or 3. Exclusion criteria were as follows: severe cardiac arrhythmia, peripheral artery disease, an ejection fraction <30%, any pulmonary pathology preventing a respiratory volume >6 ml/kg/min on mechanical ventilation, and hepatic or renal impairment. The study protocol was approved by the local ethics committee of Marmara University Medical Faculty (03.01.2020- 09.2020.158). All patients provided informed consent prior to study entry and the study was conducted in accordance with the Declaration of Helsinki.
Study groups Patients were randomly assigned to the PVI group or control group using sealed envelope method. Fluid management was based on PVI values in the PVI group, where a PVI value <13% was targeted throughout the operation. Standard fluid management regimen was used for the controls. All patients fasted for eight hours before the operation. In the operating room, all patients were monitored for PVI; however, anesthesia team was able to see only the PVI values of the PVI groups that would aid fluid management; whereas team was blinded to the PVI values of the controls in whom the fluid management was done using standard approach. On the other hand, PVI values of the controls were also recorded by another anesthesiologist every 15 minutes.
Anesthesia management For anesthesia induction, 2 mg/kg propofol and 1μgr/kg remifentanil were used in all patients and 0.6 mg/kg rocuronium (Esmeron vial, Schering -Plough, Istanbul, Turkey) was used for muscle relaxation. Following endotracheal intubation, total intravenous anesthesia with propofol and remifentanil was used. In addition to PVI, both groups were monitored for other parameters such as heart rate (HR), noninvasive mean blood pressure (MAB), and perfusion index (PI), and bispectral index scale (BIS). Propofol dose was adjusted to keep BIS between 40 and 45 throughout the operation.
Fluid management Controls Following anesthesia induction, controls received crystalloid solution at an infusion rate of 4-8 ml/kg/h for fluid maintenance. Infusion rate was adjusted by the same anesthesiologist based on routine approach based on intraoperative assessments such as heart rate, mean arterial pressure and urine output. In case of hypotension, which was defined as mean arterial blood pressure <65 mmHg, crystalloid infusion was increased and colloid infusion (Gelofusine® Melsungen, Germany) was started. In case hypotension persists, 5 mg of ephedrine was administered intravenously, and it was repeated every 5 minutes until mean arterial blood pressure is above 65 mmHg.
PVI group Crystalloid replacement was adjusted according the PVI values, which were targeted to be kept below 13% above 5%. Fluid maintenance was started with 2ml/kg/hour crystalloid dose. If PVI is >13% for more than 5 minutes, a 250 ml bolus Gelofusine® was administered. If PVI was still >13% following this, it was repeated every 5 minutes until PVI<13%. Meanwhile, 5 mg bolus ephedrine was administered to keep mean blood pressure over 65 mmHg, when necessary. In case mean blood pressure is <65 mmHg, intravenous 5 mg ephedrine was repeated every 5 minutes until mean blood pressure is over 65 mmHg.
Assessments Following parameters were recorded intraoperatively at 15 minutes intervals: PVI value, heart rate, mean arterial pressure, perfusion index value. In addition, preoperative bun, creatinine, and lactate values, perioperative use of crystalloids, colloids, blood/blood products, and bleeding amounts, intra- and postoperative urine outputs, as well as postoperative bun, creatinine, lactate values were recorded.
- Conditions
- Obesity
- Keywords
- obesity, fluid therapy, pleth variability index
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid therapy in bariatric patients
Fluid therapy is providewith pleth variability index monitorisation
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start10 Jan 2021
- Primary completion10 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliha Orhon, Marmara University
- Investigators
- MELIHA ORHON ERGUN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855318
- Sponsor's protocol ID
- 09.2020.158
- Status last verified
- Jun 2021
- First submitted
- 4 Apr 2021
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plethysmographic Variability Index Monitoring on Fluid Replacement in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04855318
- Acronym / sponsor ID
- 09.2020.158
- Conditions
- Obesity
- Keywords
- obesity, fluid therapy, pleth variability index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 22 Apr 2021 (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 frequency of obese postoperative rhabdomyolized acute tubular necrosis (ATN) and renal failure is also increasing. It is simply important to manage fluid. The fluid requirement should be higher than planned. In order to learn the postoperative ATN and the development of renal failure, 4-5 lt crystalloid fluid should be given in 2-3 times or 1.5 ml / kg / h should be provided in the upper outlet.
According to TVA, there are no good guidelines for intraoperative fluid management in bariatric surgery. Different intraoperative fluid management communications are used. The key to improving outcomes from post-operative treatment is "patient directed fluid management" or "targeted fluid management". The use of Perioperative Goal-Directed Fluid Therapy Technologies helps the anesthesiologist closely monitor the patient and strike the delicate balance between benefit and risk. Plethysmographic variability index monitoring (PVI-Pleth Variability Index) is a non-invasive, automatic and continuous monitor that displays patient fluid response, it is one of the easily applicable and easily interpreted monitoring methods. With PVI monitoring, intraoperative hypotension and fluid need can be predicted in advance.
Plethysmographic Variability Index (PVI) is the determination of the importance of monitoring of intraoperative volume replacement and its effect on postoperative operations.
Detailed description
Obesity is defined as an increase in body weight beyond requirements as a result of excessive fat accumulation in the body and is common Obesity leads to an increase in health problems and morbidity and mortality, as well as individual and social problems and a decrease in the workforce. Despite sports, diet, lifestyle changes and medical treatments, the rate of obesity continues to increase in the population. The most effective and durable treatment option for morbid obesity is bariatric surgery. Video laparoscopic bariatric surgery (VLBS) is recognized as the best surgical technique for morbidly obese individuals with health complications associated with excess body fat. Despite the proven benefits of VLBS, it can model a systemic inflammatory response. VLBS also poses an inherent risk of pneumoperitoneum for the kidneys due to high intra-abdominal pressure, which reduces cortical capillary blood flow by increasing renal vascular resistance. As a result, the glomerular filtration rate (GFR) decreases and transient oliguria occurs. Acute renal failure manifested as a large increase in creatinine levels with oliguria.
It is a preventable complication with intraoperative anesthesia management.Glomerular filtration rate (GFR) and increased renal plasma flow cause hyperfiltration syndrome in obesity. Adinopectin, proinflammatory cytokines, oxidative stress and pharmacological nephrotoxicity are the mechanisms affecting acute kidney injury in obesity. Chronic renal failure occurs as a result of a decrease in albiminuria and GFR. They are the causes of postoperative renal failure in patients with diabetes, a history of kidney disease, using antihypertensive drugs containing diuretics, and obese patients with a BMI greater than 50 kg / m2, prolonged operation time, and intraoperative hypotension.
The frequency of acute tubular necrosis (ATN) and renal failure due to postoperative rhabdomyolysis is also increased in obese patients. Fluid management is important to prevent this. The fluid requirement should be higher than planned. In order to prevent the development of postoperative ATN and renal failure, 4-5 liters of crystalloid fluid should be given in 2-3 hours or urine output above 1.5 ml / kg / h should be provided.
According to TVA, there are studies performing crystalloid fluid replacement in a wide range of 15-40 ml / kg.
In obese patients, changes in distribution volume such as decreased hepatic blood flow, increase in renal blood flow and glomerular filtration rate and increase in the amount of free-flowing drug are the most important factors affecting the pharmacokinetics of drugs. Drug doses used in these patients are recommended to be calculated according to total body weight (TVA), ideal body weight (IVA), and lean body weight (HVA = IVA + 20%), taking into account the lipophilic nature of the drug. For example in induction; when using high lipophilic drugs according to YVA or IVA; moderately lipophilic For drugs, the dosage can be increased by 20-40% and used according to the YVA.Propofol's high lipophilic properties cause its effect to start very quickly and to be short-lived. It has been shown in many studies that there is no usable accumulation or prolongation of propofol compared to TVA in obese patients.
Short-acting remifentanil, one of the lipophilic synthetic opioids, can be administered according to IVA .
There are no well-known guidelines for intraoperative fluid management in bariatric surgery. Different intraoperative fluid management protocols are used. The key to improving outcomes from treatment in the post-operative period is "patient directed fluid management" or "targeted fluid management". The use of Perioperative Goal-Directed Fluid Therapy Technologies helps the anesthesiologist to closely monitor the patient and establish the delicate balance between benefit and risk. Plethysmographic variability index monitoring (PVI-Pleth Variability Index) is a non-invasive, automatic and continuous monitor that displays the fluid response of patients, and is one of the easy-to-apply and easily interpreted monitoring methods. It has been shown that intraoperative hypotension and fluid need can be predicted with PVI monitoring.
The aim of this study is to determine the effect of Pleth Variability Index (PVI) monitoring on intraoperative volume replacement amount and postoperative complications in obese patients who underwent bariatric surgery.
Patients and Methods
Patients A total of 60 obese patients who scheduled for elective bariatric surgery were included in this single-blind prospective randomized study. Patients were required to have an ASA physical status class 2 or 3. Exclusion criteria were as follows: severe cardiac arrhythmia, peripheral artery disease, an ejection fraction <30%, any pulmonary pathology preventing a respiratory volume >6 ml/kg/min on mechanical ventilation, and hepatic or renal impairment. The study protocol was approved by the local ethics committee of Marmara University Medical Faculty (03.01.2020- 09.2020.158). All patients provided informed consent prior to study entry and the study was conducted in accordance with the Declaration of Helsinki.
Study groups Patients were randomly assigned to the PVI group or control group using sealed envelope method. Fluid management was based on PVI values in the PVI group, where a PVI value <13% was targeted throughout the operation. Standard fluid management regimen was used for the controls. All patients fasted for eight hours before the operation. In the operating room, all patients were monitored for PVI; however, anesthesia team was able to see only the PVI values of the PVI groups that would aid fluid management; whereas team was blinded to the PVI values of the controls in whom the fluid management was done using standard approach. On the other hand, PVI values of the controls were also recorded by another anesthesiologist every 15 minutes.
Anesthesia management For anesthesia induction, 2 mg/kg propofol and 1μgr/kg remifentanil were used in all patients and 0.6 mg/kg rocuronium (Esmeron vial, Schering -Plough, Istanbul, Turkey) was used for muscle relaxation. Following endotracheal intubation, total intravenous anesthesia with propofol and remifentanil was used. In addition to PVI, both groups were monitored for other parameters such as heart rate (HR), noninvasive mean blood pressure (MAB), and perfusion index (PI), and bispectral index scale (BIS). Propofol dose was adjusted to keep BIS between 40 and 45 throughout the operation.
Fluid management Controls Following anesthesia induction, controls received crystalloid solution at an infusion rate of 4-8 ml/kg/h for fluid maintenance. Infusion rate was adjusted by the same anesthesiologist based on routine approach based on intraoperative assessments such as heart rate, mean arterial pressure and urine output. In case of hypotension, which was defined as mean arterial blood pressure <65 mmHg, crystalloid infusion was increased and colloid infusion (Gelofusine® Melsungen, Germany) was started. In case hypotension persists, 5 mg of ephedrine was administered intravenously, and it was repeated every 5 minutes until mean arterial blood pressure is above 65 mmHg.
PVI group Crystalloid replacement was adjusted according the PVI values, which were targeted to be kept below 13% above 5%. Fluid maintenance was started with 2ml/kg/hour crystalloid dose. If PVI is >13% for more than 5 minutes, a 250 ml bolus Gelofusine® was administered. If PVI was still >13% following this, it was repeated every 5 minutes until PVI<13%. Meanwhile, 5 mg bolus ephedrine was administered to keep mean blood pressure over 65 mmHg, when necessary. In case mean blood pressure is <65 mmHg, intravenous 5 mg ephedrine was repeated every 5 minutes until mean blood pressure is over 65 mmHg.
Assessments Following parameters were recorded intraoperatively at 15 minutes intervals: PVI value, heart rate, mean arterial pressure, perfusion index value. In addition, preoperative bun, creatinine, and lactate values, perioperative use of crystalloids, colloids, blood/blood products, and bleeding amounts, intra- and postoperative urine outputs, as well as postoperative bun, creatinine, lactate values were recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- sample size 60
Key inclusion criteria (1 listed)
- obese patients who scheduled for elective bariatric surgery
Key exclusion criteria (5 listed)
- severe cardiac arrhythmia
- peripheral artery disease
- an ejection fraction <30%
- any pulmonary pathology preventing a respiratory volume >6 ml/kg/min on mechanical ventilation
- hepatic or renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fluid therapy in bariatric patients
Time frame: during surgery
Fluid therapy is providewith pleth variability index monitorisation
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 31 Mar 2022.
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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.
MELIHA ORHON ERGUN principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Marmara University at 1 site in Turkey (Türkiye).
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 5 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 31 Mar 2022. 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 Turkey (Türkiye). 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?
Fluid therapy in bariatric patients (time frame: during 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 31 Mar 2022.