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Trial Outcomes & Findings for The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients. (NCT NCT01675453)

NCT ID: NCT01675453

Last Updated: 2016-05-27

Results Overview

Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight".

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1

Results posted on

2016-05-27

Participant Flow

Participant milestones

Participant milestones
Measure
7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)
On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5
0.9% NaCl (Control Group)
On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 0.9% NaCl
Overall Study
STARTED
20
20
Overall Study
COMPLETED
20
20
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)
n=20 Participants
On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5
0.9% NaCl (Control Group)
n=20 Participants
On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 0.9% NaCl
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
59 years
n=5 Participants
57 years
n=7 Participants
58 years
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
1 Participants
n=7 Participants
6 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
19 Participants
n=7 Participants
34 Participants
n=5 Participants
Region of Enrollment
Russian Federation
20 participants
n=5 Participants
20 participants
n=7 Participants
40 participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1

Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight".

Outcome measures

Outcome measures
Measure
7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)
n=20 Participants
On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5
0.9% NaCl (Control Group)
n=20 Participants
On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 0.9% NaCl
Extravascular Lung Water Index
5 min after CPB
9 mL/kg
Interval 8.0 to 9.0
10 mL/kg
Interval 9.0 to 10.0
Extravascular Lung Water Index
end of surgery
8 mL/kg
Interval 8.0 to 9.0
9 mL/kg
Interval 8.0 to 10.0
Extravascular Lung Water Index
2 h after CPB
8 mL/kg
Interval 8.0 to 9.0
9 mL/kg
Interval 8.0 to 10.0
Extravascular Lung Water Index
4 h after CPB
7 mL/kg
Interval 6.0 to 8.0
9 mL/kg
Interval 8.0 to 10.0
Extravascular Lung Water Index
6 h after CPB
7 mL/kg
Interval 6.0 to 7.0
9 mL/kg
Interval 8.0 to 10.0
Extravascular Lung Water Index
12 h after CPB
7 mL/kg
Interval 6.0 to 8.0
9 mL/kg
Interval 8.0 to 10.0
Extravascular Lung Water Index
baseline
9 mL/kg
Interval 8.0 to 10.0
8 mL/kg
Interval 8.0 to 9.0
Extravascular Lung Water Index
5 min after infusion
9 mL/kg
Interval 8.0 to 10.0
8 mL/kg
Interval 8.0 to 10.0
Extravascular Lung Water Index
30 min after CPB
9 mL/kg
Interval 8.0 to 9.0
9 mL/kg
Interval 9.0 to 10.0
Extravascular Lung Water Index
POD 1
7 mL/kg
Interval 7.0 to 8.0
9 mL/kg
Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: 24 hours

Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Oxygen delivery index (DO2I) will be used to assess this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Delirium, clinically diagnosed stroke, and encephalopathy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Bleeding from chest tubes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 h

The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay

Outcome measures

Outcome data not reported

Adverse Events

7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

0.9% NaCl (Control Group)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Evgeny Fominskiy

Academician EN Meshalkin State Budget Research Institute of Circulation Pathology

Phone: +79139538754

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place