Clinical Trial Results:
Reducing high intraocular pressure with hypertonic saline infusion before eyesurgery
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Summary
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EudraCT number |
2012-005025-70 |
Trial protocol |
FI |
Global end of trial date |
01 Jan 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Jan 2025
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First version publication date |
24 Jan 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
003,1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Helsinki University Central Hospital
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Sponsor organisation address |
Haartmaninkatu 4 C, Helsinki, Finland, 00029
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Public contact |
Department of Ophthalmology, Helsinki University Central Hospital, +358 503804997, ext-pia.inborr@hus.fi
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Scientific contact |
Department of Ophthalmology, Helsinki University Central Hospital, +358 503804997, ext-pia.inborr@hus.fi
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Dec 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Jan 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jan 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Change in ocular pressure
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Protection of trial subjects |
We required the patients to be fluent in Finnish or Swedish. We excluded patients diagnosed with heart and kidney failure, dementia, or another condition that markedly decreased their physical performance. We measured blood pressure and heart rate automatically with an anaesthesia monitor. We took measurements before the bolus (baseline), 5, 10, 20 and 30 minutes after the bolus. We asked the patients to grade the pain at the infusion site on a scale from 0 to 10; zero for no pain, and 10 for the most intense (intolerable) pain. Any other side effect was additionally recorded.
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Background therapy |
We cannulated an antecubital vein in either the right or left arm. We rinsed the cannula with 3 ml physiologic saline to confirm its intravenous position. The IVTHS dose corresponds to a 20 ml injection for an 80 kg patient. We infused the bolus at 1 ml/s, and then rinsed the cannula and vein with physiologic saline using 5 ml after the bolus. The mannitol dose corresponds to a 210 for an 80 kg patient. We infused mannitol during 30 minutes time. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 11
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Worldwide total number of subjects |
11
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EEA total number of subjects |
11
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
6
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were 25-80 years old. We required the patients to be fluent in Finnish or Swedish. Patients on oral acetazolamide or other medication that could lower blood natrium levels, patients with heart or kidney failure, dementia, any other condition that remarkably decreased the patients’ physical performance were ineligible. | |||||||||
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Pre-assignment
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Screening details |
We recruited study patients among patients who come to HUCH eye hospital for eye surgery. Intra ocular pressure had to be 30 mmHg of more. | |||||||||
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Period 1
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Period 1 title |
Recruit (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
We used Stata randomiser program to divide patients between two study groups.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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NaCl group | |||||||||
Arm description |
Patients who received 23.4% NaCl infusion before eye surgery. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Natriumklorid Braun 234 mg/ml
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection/infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
We cannulated an antecubital vein in either the right or left arm. We rinsed the cannula with 3 ml physiologic saline to confirm its intravenous position. The dosage of IVHTS was 1 mmol/kg sodium chloride in all patients. We infused the bolus at 1 ml/s, and then rinsed the cannula and vein with physiologic saline using 5 ml after the bolus.
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Arm title
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Mannitol group | |||||||||
Arm description |
Patients who received mannitol infusion before eye surgery. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Mannitol Braun 150 mg/ml infusion fluid
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravascular use
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Dosage and administration details |
We cannulated an antecubital vein in either the right or left arm. We rinsed the cannula with 3 ml physiologic saline to confirm its intravenous position. We gave Mannitol Braun 150 mg/ml (15%) or 0,15 g/ml intravenously. Dosage was 0.4 g/kg. Maximum dosage was 270 ml. We gave mannitol infusion during 30 minutes time.
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Baseline characteristics reporting groups
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Reporting group title |
NaCl group
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Reporting group description |
Patients who received 23.4% NaCl infusion before eye surgery. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mannitol group
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Reporting group description |
Patients who received mannitol infusion before eye surgery. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
NaCl group
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Reporting group description |
Patients who received 23.4% NaCl infusion before eye surgery. | ||
Reporting group title |
Mannitol group
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Reporting group description |
Patients who received mannitol infusion before eye surgery. | ||
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End point title |
Chance in intra ocular pressure 30 minutes after injection/infusion [1] | ||||||||||||
End point description |
We measured intra ocular pressure at baseline and 30 minutes after 23.4% natrium cloride injection or mannitol infusion with iCare gauge. We took three measurements and calculated average. Then we calculated the change in intraocular pressure.
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End point type |
Primary
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End point timeframe |
Change in intra ocular pressure 30 minutes after 23.4% natrium cloride injection or mannitol infusion.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Early termination, no final results to be analysed. |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
30 minutes after 23.4% natrium cloride injection or mannitol infusion.
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Adverse event reporting additional description |
We asked the patients to grade the pain at the infusion site on a scale from 0 to 10; zero for no pain, and 10 for the most intense (intolerable) pain. Any other side effect was additionally recorded.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
VAS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
NaCl group
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Reporting group description |
Patients who received 23.4% NaCl bolus before eye surgery. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mannitol group
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Reporting group description |
Patients who received mannitol infusion before eye surgery. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| We planned to study minimum 23 patients per group to show that hypertonic NaCl in as effective as mannitol to reduce intra ocular pressure 30 minutes after injection. We had difficulties to find patients who meet the exclusion criteria. | |||
