CraniotomyNCT02237716
Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery
An observational study of Craniotomy, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Craniotomy
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: scheduled for elective craniotomy
Who may be able to join
- The inclusion criteria were: being aged between 16 and 70 years;
- with a body mass index of 18-25 kg/m2;
- with a physical status classified as ASA class I or II;
- and scheduled for elective craniotomy
Who cannot join
- Any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia;
- had a previous history of intra-aortic balloon counterpulsation;
- exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100 mmHg, or heart rate ≥ 100 bpm on operating room admission;
- or rejected to participate in this study.
About this study
The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min and 10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P < 0.001), which returned to the baseline after 20 min.
- Conditions
- Craniotomy
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac index
Measured: during the procedure
stroke volume index
Measured: during the procedure
stroke volume variation
Measured: during the procedure
systolic pressure
Measured: during the procedure
central venous pressure
Measured: during the procedure
heart rate
Measured: during the procedure
peripheral vascular resistance
Measured: during the procedure
Secondary outcomes (3)
base excess
Measured: during the procedure
lactic acid
Measured: during the procedure
DO2I
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinxin Shao, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237716
- Sponsor's protocol ID
- MN2014
- Status last verified
- Sep 2014
- First submitted
- 26 Aug 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery
- ClinicalTrials.gov ID
- NCT02237716
- Acronym / sponsor ID
- MN2014
- Conditions
- Craniotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 11 Sep 2014 (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.
The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min and 10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P < 0.001), which returned to the baseline after 20 min.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- scheduled for elective craniotomy
Key inclusion criteria (4 listed)
- The inclusion criteria were: being aged between 16 and 70 years;
- with a body mass index of 18-25 kg/m2;
- with a physical status classified as ASA class I or II;
- and scheduled for elective craniotomy
Key exclusion criteria (4 listed)
- Any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia;
- had a previous history of intra-aortic balloon counterpulsation;
- exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100 mmHg, or heart rate ≥ 100 bpm on operating room admission;
- or rejected to participate in this study.
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
cardiac index
Time frame: during the procedure
stroke volume index
Time frame: during the procedure
stroke volume variation
Time frame: during the procedure
systolic pressure
Time frame: during the procedure
central venous pressure
Time frame: during the procedure
heart rate
Time frame: during the procedure
peripheral vascular resistance
Time frame: during the procedure
3 secondary outcomes
base excess
Time frame: during the procedure
lactic acid
Time frame: during the procedure
DO2I
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniotomy, run by First Affiliated Hospital, Sun Yat-Sen 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 4 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: status not confirmed, as of the sponsor's last update on 11 Sep 2014. 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.
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?
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?
cardiac index (time frame: during the procedure). The study lists 7 primary outcomes in all. 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 11 Sep 2014.