PerfusionNCT03048162
The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index
A study testing sodium chloride, Hydroxyethylstarch and Ringer-Lactate Infusion Solution Bag in people with Perfusion, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be randomly divided into three groups. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Perfusion
- What is being tested?
- sodium chloride, Hydroxyethylstarch and Ringer-Lactate Infusion Solution Bag
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2017to 15 May 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having a fasting period of 8 hours
- quit smoking for 8 hours before the procedure
Who cannot join
- not to participate in the study
- presence of peripheral vascular disease
- a history of upper extremity surgery
- presence of any kind of psychiatric disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60200
About this study
Official title: The Evaluation of the Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index
This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.
Read the detailed description
Intravenous volume replacement alter the dynamics of microcirculation. Perfusion index and pulse variability index are the recent parameters to evaluate the tissue microcirculatory condition. This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be taken to recovery room in the operating theatre and wait for 15 minutes to balance the skin temperature of the patients to the environment. Patients will be randomly divided into three groups using closed envelope technique as Group L (received 500 ml of Ringer's lactate), Group S (500 ml of saline) and Group H (received 500 ml of 6% hydroxyethylstarch). Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.
- Conditions
- Perfusion
- Being tested
- sodium chloride, Hydroxyethylstarch, Ringer-Lactate Infusion Solution Bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium chlorideDrug
500 ml of 0.9% isotonic sodium chloride
HydroxyethylstarchDrug
500 ml of 6% Hydroxyethylstarch
Ringer-Lactate Infusion Solution BagDrug
500 ml of Ringer-Lactate Infusion Solution Bag
| Study group | Role | What they receive |
|---|---|---|
| sodium chloride | Active comparator | 0.9% isotonic sodium chloride, 500 ml, one package in 30 minutes Receives: Drug: sodium chloride |
| Hydroxyethylstarch | Active comparator | 6% hydroxyethylstarch, 500 ml, one package in 30 minutes Receives: Drug: Hydroxyethylstarch |
| Ringer-Lactate Infusion Solution Bag | Active comparator | Ringer's lactate, 500 ml, one package in 30 minutes Receives: Drug: Ringer-Lactate Infusion Solution Bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index
The perfusion of the tissues
Measured: six months
Secondary outcomes (4)
Heart rate
Heart rate
Measured: six months
Blood pressure
Non-invasive lood pressure
Measured: six months
Oxygen saturation
Blood oxygen saturation using pulse oximeter
Measured: six months
Pulse variability index
The intravenous fluid requirement of the tissues
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start13 Feb 2017
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerfusionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Dogru, Tokat Gaziosmanpasa University
- Investigators
- Seval Ekerer, Dr, Principal investigator, Gaziosmanpasa UniversityMustafa Suren, Dr, Principal investigator, Gaziosmanpasa UniversitySerkan Karaman, Dr, Principal investigator, Gaziosmanpasa UniversityTugba Karaman, Dr, Principal investigator, Gaziosmanpasa UniversityHakan Tapar, Dr, Principal investigator, Gaziosmanpasa UniversityAynur Sahin, Dr, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048162
- Sponsor's protocol ID
- OMU KAEK 2016/390
- Status last verified
- May 2017
- First submitted
- 4 Feb 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index
- ClinicalTrials.gov ID
- NCT03048162
- Acronym / sponsor ID
- OMU KAEK 2016/390
- Conditions
- Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.
Detailed description
Intravenous volume replacement alter the dynamics of microcirculation. Perfusion index and pulse variability index are the recent parameters to evaluate the tissue microcirculatory condition. This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be taken to recovery room in the operating theatre and wait for 15 minutes to balance the skin temperature of the patients to the environment. Patients will be randomly divided into three groups using closed envelope technique as Group L (received 500 ml of Ringer's lactate), Group S (500 ml of saline) and Group H (received 500 ml of 6% hydroxyethylstarch). Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sodium chloride | Active comparator | Drug: sodium chloride0.9% isotonic sodium chloride, 500 ml, one package in 30 minutes |
| Hydroxyethylstarch | Active comparator | Drug: Hydroxyethylstarch6% hydroxyethylstarch, 500 ml, one package in 30 minutes |
| Ringer-Lactate Infusion Solution Bag | Active comparator | Drug: Ringer-Lactate Infusion Solution BagRinger's lactate, 500 ml, one package in 30 minutes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- having a fasting period of 8 hours
- quit smoking for 8 hours before the procedure
Key exclusion criteria (4 listed)
- not to participate in the study
- presence of peripheral vascular disease
- a history of upper extremity surgery
- presence of any kind of psychiatric disease
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 |
|---|---|---|
| sodium chloride500 ml of 0.9% isotonic sodium chloride | Drug | sodium chloride |
| Hydroxyethylstarch500 ml of 6% Hydroxyethylstarch | Drug | Hydroxyethylstarch |
| Ringer-Lactate Infusion Solution Bag500 ml of Ringer-Lactate Infusion Solution Bag | Drug | Ringer-Lactate Infusion Solution Bag |
Primary outcome
Perfusion index
Time frame: six months
The perfusion of the tissues
4 secondary outcomes
Heart rate
Time frame: six months
Blood pressure
Time frame: six months
Oxygen saturation
Time frame: six months
Pulse variability index
Time frame: six months
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 16 May 2017.
- 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.
Seval Ekerer, Dr principal investigator
Gaziosmanpasa University
Mustafa Suren, Dr principal investigator
Gaziosmanpasa University
Serkan Karaman, Dr principal investigator
Gaziosmanpasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium chloride, Hydroxyethylstarch and Ringer-Lactate Infusion Solution Bag in people with Perfusion, run by Tokat Gaziosmanpasa 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 2 inclusion and 4 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 16 May 2017. 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?
Perfusion index (time frame: six months). 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 16 May 2017.