Trial · NCT01675453
The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
NCT01675453, Phase 2, Completed, Meshalkin Research Institute of Pathology of Circulation; results first posted 2014-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients. Trials, record NCT01675453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01675453
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
- NCT number
- NCT01675453
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Conditions
- Coronary Artery Disease, Edema
- Interventions
- 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5, 0.9% NaCl
- First posted
- 2012-08-30
- Last updated
- 2016-05-27
- Results first posted
- 2014-06-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Extravascular Lung Water Index | 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". |
| Secondary | Pulmonary Oxygenation | 24 hours | Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure. |
| Secondary | Oxygen Delivery | 24 hours | Oxygen delivery index (DO2I) will be used to assess this outcome measure. |
| Secondary | Cardiac Index | 24 hours | |
| Secondary | Fluid Balance | 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. |
| Secondary | Inflammation Response | 24 hours | Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure. |
| Secondary | Endothelial Integrity | 24 hours | Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure. |
| Secondary | Plasma Na | 24 hours | |
| Secondary | Plasma Osmolarity | 24 hours | |
| Secondary | Rate of Acute Kidney Injury | 48 hours | serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Extravascular Lung Water Index | 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 | mL/kg | MEDIAN | |
| SECONDARY | Pulmonary Oxygenation | 24 hours | |||
| SECONDARY | Oxygen Delivery | 24 hours | |||
| SECONDARY | Cardiac Index | 24 hours | |||
| SECONDARY | Fluid Balance | 24 hours | |||
| SECONDARY | Inflammation Response | 24 hours | |||
| SECONDARY | Endothelial Integrity | 24 hours | |||
| SECONDARY | Plasma Na | 24 hours | |||
| SECONDARY | Plasma Osmolarity | 24 hours | |||
| SECONDARY | Rate of Acute Kidney Injury | 48 hours |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Extravascular Lung Water Index | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | baseline | 9 | Inter-Quartile Range 8 to 10 | mL/kg |
| Extravascular Lung Water Index | 0.9% NaCl (Control Group) | baseline | 8 | Inter-Quartile Range 8 to 9 | mL/kg |
| Extravascular Lung Water Index | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | 5 min after infusion | 9 | Inter-Quartile Range 8 to 10 | mL/kg |
| Extravascular Lung Water Index | 0.9% NaCl (Control Group) | 5 min after infusion | 8 | Inter-Quartile Range 8 to 10 | mL/kg |
| Extravascular Lung Water Index | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | 5 min after CPB | 9 | Inter-Quartile Range 8 to 9 | mL/kg |
| Extravascular Lung Water Index | 0.9% NaCl (Control Group) | 5 min after CPB | 10 | Inter-Quartile Range 9 to 10 | mL/kg |
| Extravascular Lung Water Index | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | 30 min after CPB | 9 | Inter-Quartile Range 8 to 9 | mL/kg |
| Extravascular Lung Water Index | 0.9% NaCl (Control Group) | 30 min after CPB | 9 | Inter-Quartile Range 9 to 10 | mL/kg |
| Extravascular Lung Water Index | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | end of surgery | 8 | Inter-Quartile Range 8 to 9 | mL/kg |
| Extravascular Lung Water Index | 0.9% NaCl (Control Group) | end of surgery | 9 | Inter-Quartile Range 8 to 10 | mL/kg |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | 20 | |
| Overall Study | STARTED | 0.9% NaCl (Control Group) | 20 | |
| Overall Study | COMPLETED | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | 20 | |
| Overall Study | COMPLETED | 0.9% NaCl (Control Group) | 20 | |
| Overall Study | NOT COMPLETED | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | 0 | |
| Overall Study | NOT COMPLETED | 0.9% NaCl (Control Group) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | ||
| Total, all-cause mortality | 0.9% NaCl (Control Group) | ||
| Total, other adverse events | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | 0 | 20 |
| Total, other adverse events | 0.9% NaCl (Control Group) | 0 | 20 |
| Total, serious adverse events | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | 0 | 20 |
| Total, serious adverse events | 0.9% NaCl (Control Group) | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24549094 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) vs 0.9% NaCl (Control Group): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01675453
GET https://conductscience.org/api/trials/v1/NCT01675453/registered