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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02537106
Other study ID # 201508-S23P
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date May 2019

Study information

Verified date September 2019
Source University Hospital Hradec Kralove
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hyperosmotic solutions of 1.5% and 3% NaCl are equally effective for brain relaxation and microcirculation during brain surgery. The effect of 1.5% NaCl on postoperative natremia and natriuresis is less pronounced.


Description:

All the patients meeting the study criteria will be randomized into two groups. After standardized induction to general anesthesia all patients will be given the infusion of hyperosmotic NaCl 5 ml/kg/BW during 30 min, group A 1.5% NaCl, group B 3% NaCl. Corticosteroids will be administered as usually. After dura opening the brain relaxation score will be assessed by surgeon (1 = completely relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain), and the first measurement of the brain microcirculation provided by use of SDF probe in the area of the healthy brain, and of perifocal oedema. Both sites of investigation will be marked for the second measurement, which will be done after the end of tumor resection. Laboratory examinations: natremia preoperatively, natremia and osmolarity peroperatively 1 hour after NaCl infusion and at the end of surgery. Concentration of natrium will be examined in CSF after dura opening. Anesthesia management will be according to the standardised protocol, the patients will be awaken and extubated after the end of the procedure at the operating theatre.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- peripheral supratentorial brain tumors or metastasis

- indication for osmotherapy

- ASA status I-III

Exclusion Criteria:

- reoperation

- osmotherapy prior to surgery

- preoperative natremia less than 135 mmol/l and more than 140 mmol/l

- GCS less than 14

- obstructive hydrocephalus

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
1.5% NaCl
After the infusion of 1.5% NaCl and dura opening the microcirculation and the brain relaxation score will be measured in the area of healthy brain and perifocal oedema sites. Microcirculation measurement will be repeated at the same sites after tumor resection.
3% NaCl
After the infusion of 3% NaCl and dura opening the microcirculation and the brain relaxation score will be measured in the area of healthy brain and perifocal oedema sites. Microcirculation measurement will be repeated at the same sites after tumor resection.

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Kralove

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in diuresis ml/hour at the time of extubation
Primary Changes in brain microcirculation measurement by SDF probe MicroVision from dura opening till the end of tumor resection
Secondary Changes in natremia mmol/l 1 hour after hypertonic NaCl infusion
Secondary Changes in natremia mmol/l 5 min after the end of surgery
Secondary Changes in osmolarity mosm/l 1 hour after hypertonic NaCl infusion
Secondary Changes in osmolarity mosm/l 5 min after the end of surgery
Secondary Concentration of natrium in cerebrospinal fluid mmol/l after dura opening
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