Postoperative Cardiorespiratory FailurePhase 4HHNCT00469716
Hypertonic Saline-hetastarch in Cardiac Surgery
A Phase 4 study testing Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5) in people with Postoperative Cardiorespiratory Failure, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal model. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cardiorespiratory Failure
- What is being tested?
- Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2007to May 2008
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective coronary artery bypass graft surgery
Who cannot join
- Age <18 years or > 75 years
- BMI< 18 or > 30
- Left ventricular ejection fraction < 40%
- Emergency operations
- Additional valvular diseases
- Impaired renal function
Show all 9Show fewer
- Serum sodium> 145 mmol/l
- Hematocrit< 30%
- Use of clopidogrel the last 5 days
Trial locations and contacts
1 site in 1 country.
Norway1 site
Section for thoracic and cardiovascular surgery, Haukeland University Hospital
Bergen, 5021
About this study
Official title: Infusion of Hypertonic Saline-hetastarch in Cardiac Surgery
Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.
Read the detailed description
Cardiopulmonary bypass (CPB) is associated with fluid overload and edema formation occasionally resulting in vital organ dysfunction affecting heart, respiratory system , gastrointestinal tract and brain. Hyperosmolar/hyperoncotic preparations (HSH/HSD) have been used in cardiac surgery essentially with the aim to mobilize fluid excess and improve postoperative cardiorespiratory function.Most studies dealing with the administration of HSD or HSH during and after CPB, have used protocols recommended for treatment of severe hypovolemia and shock, that is 4 mL/kg as a bolus, given within minutes.In animal experiments we have used HSD or HSH, 1 mL/kg/h to a total dose of 4 mL/kg during CPB. The use of HSH/HSD reduced the total fluid gain about 50 % and resulted in significantly lower content of tissue water in vital organs as heart and lungs. In the actual clinical trial we hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions monitored with the PiCCO system in patients undergoing coronary artery bypass with CPB.
- Conditions
- Postoperative Cardiorespiratory Failure
- Being tested
- Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)
- Keywords
- Fluid balance, respiratory function, cardiac function, inflammation, Cardiopulmonary bypass
- Medical subject headings
- Respiratory Aspiration, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume
Measured: 12 hours
Secondary outcomes (1)
Time to extubation, fluid balance, paO2/FiO2- ratio, frequency of atrial fibrillation, cytokines, time to ICU-release and hospital release.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cardiorespiratory FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marit Farstad, MD, PhD, Principal investigator, Dep. of Anesthesia and Intensive Care, Haukeland University Hospital, 5021 Bergen , Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469716
- Sponsor's protocol ID
- 15789
- Acronym
- HH
- Status last verified
- Aug 2016
- First submitted
- 3 May 2007
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mehlhorn U, Geissler HJ, Laine GA, Allen SJ. Myocardial fluid balance. Eur J Cardiothorac Surg. 2001 Dec;20(6):1220-30. doi: 10.1016/s1010-7940(01)01031-4.
PubMed 11717032Kumle B, Boldt J, Suttner SW, Piper SN, Lehmann A, Blome M. Influence of prolonged cardiopulmonary bypass times on splanchnic perfusion and markers of splanchnic organ function. Ann Thorac Surg. 2003 May;75(5):1558-64. doi: 10.1016/s0003-4975(02)04903-2.
PubMed 12735579Harris DN, Oatridge A, Dob D, Smith PL, Taylor KM, Bydder GM. Cerebral swelling after normothermic cardiopulmonary bypass. Anesthesiology. 1998 Feb;88(2):340-5. doi: 10.1097/00000542-199802000-00011.
PubMed 9477053Harris DN, Bailey SM, Smith PL, Taylor KM, Oatridge A, Bydder GM. Brain swelling in first hour after coronary artery bypass surgery. Lancet. 1993 Sep 4;342(8871):586-7. doi: 10.1016/0140-6736(93)91412-f.
PubMed 8102722McDaniel LB, Nguyen T, Zwischenberger JB, Vertrees R, Uchida T, Kramer GC. Hypertonic saline dextran prime reduces increased intracranial pressure during cardiopulmonary bypass in pigs. Anesth Analg. 1994 Mar;78(3):435-41. doi: 10.1213/00000539-199403000-00003.
PubMed 8109757Bueno R, Resende AC, Melo R, Neto VA, Stolf NA. Effects of hypertonic saline-dextran solution in cardiac valve surgery with cardiopulmonary bypass. Ann Thorac Surg. 2004 Feb;77(2):604-11; discussion 611. doi: 10.1016/S0003-4975(03)01486-3.
PubMed 14759446Farstad M, Haugen O, Kvalheim VL, Hammersborg SM, Rynning SE, Mongstad A, Nygreen E, Husby P. Reduced fluid gain during cardiopulmonary bypass in piglets using a continuous infusion of a hyperosmolar/hyperoncotic solution. Acta Anaesthesiol Scand. 2006 Aug;50(7):855-62. doi: 10.1111/j.1399-6576.2006.01064.x.
PubMed 16879469
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of Hypertonic Saline-hetastarch in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00469716
- Acronym / sponsor ID
- HH / 15789
- Conditions
- Postoperative Cardiorespiratory Failure
- Keywords
- Fluid balance, respiratory function, cardiac function, inflammation, Cardiopulmonary bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 May 2007 (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.
Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.
Detailed description
Cardiopulmonary bypass (CPB) is associated with fluid overload and edema formation occasionally resulting in vital organ dysfunction affecting heart, respiratory system , gastrointestinal tract and brain. Hyperosmolar/hyperoncotic preparations (HSH/HSD) have been used in cardiac surgery essentially with the aim to mobilize fluid excess and improve postoperative cardiorespiratory function.Most studies dealing with the administration of HSD or HSH during and after CPB, have used protocols recommended for treatment of severe hypovolemia and shock, that is 4 mL/kg as a bolus, given within minutes.In animal experiments we have used HSD or HSH, 1 mL/kg/h to a total dose of 4 mL/kg during CPB. The use of HSH/HSD reduced the total fluid gain about 50 % and resulted in significantly lower content of tissue water in vital organs as heart and lungs. In the actual clinical trial we hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions monitored with the PiCCO system in patients undergoing coronary artery bypass with CPB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective coronary artery bypass graft surgery
Key exclusion criteria (9 listed)
- Age <18 years or > 75 years
- BMI< 18 or > 30
- Left ventricular ejection fraction < 40%
- Emergency operations
- Additional valvular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5) | Drug | – |
Primary outcome
Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume
Time frame: 12 hours
1 secondary outcome
Time to extubation, fluid balance, paO2/FiO2- ratio, frequency of atrial fibrillation, cytokines, time to ICU-release and hospital release.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Background: PubMed 11717032Mehlhorn U, Geissler HJ, Laine GA, Allen SJ. Myocardial fluid balance. Eur J Cardiothorac Surg. 2001 Dec;20(6):1220-30. doi: 10.1016/s1010-7940(01)01031-4.
- Background: PubMed 12735579Kumle B, Boldt J, Suttner SW, Piper SN, Lehmann A, Blome M. Influence of prolonged cardiopulmonary bypass times on splanchnic perfusion and markers of splanchnic organ function. Ann Thorac Surg. 2003 May;75(5):1558-64. doi: 10.1016/s0003-4975(02)04903-2.
- Background: PubMed 9477053Harris DN, Oatridge A, Dob D, Smith PL, Taylor KM, Bydder GM. Cerebral swelling after normothermic cardiopulmonary bypass. Anesthesiology. 1998 Feb;88(2):340-5. doi: 10.1097/00000542-199802000-00011.
- Background: PubMed 8102722Harris DN, Bailey SM, Smith PL, Taylor KM, Oatridge A, Bydder GM. Brain swelling in first hour after coronary artery bypass surgery. Lancet. 1993 Sep 4;342(8871):586-7. doi: 10.1016/0140-6736(93)91412-f.
- Background: PubMed 8109757McDaniel LB, Nguyen T, Zwischenberger JB, Vertrees R, Uchida T, Kramer GC. Hypertonic saline dextran prime reduces increased intracranial pressure during cardiopulmonary bypass in pigs. Anesth Analg. 1994 Mar;78(3):435-41. doi: 10.1213/00000539-199403000-00003.
- Background: PubMed 14759446Bueno R, Resende AC, Melo R, Neto VA, Stolf NA. Effects of hypertonic saline-dextran solution in cardiac valve surgery with cardiopulmonary bypass. Ann Thorac Surg. 2004 Feb;77(2):604-11; discussion 611. doi: 10.1016/S0003-4975(03)01486-3.
- Background: PubMed 16879469Farstad M, Haugen O, Kvalheim VL, Hammersborg SM, Rynning SE, Mongstad A, Nygreen E, Husby P. Reduced fluid gain during cardiopulmonary bypass in piglets using a continuous infusion of a hyperosmolar/hyperoncotic solution. Acta Anaesthesiol Scand. 2006 Aug;50(7):855-62. doi: 10.1111/j.1399-6576.2006.01064.x.
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.
Marit Farstad, MD, PhD principal investigator
Dep. of Anesthesia and Intensive Care, Haukeland University Hospital, 5021 Bergen , Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5) in people with Postoperative Cardiorespiratory Failure, run by Haukeland University Hospital at 1 site in Norway.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00469716, which also lists 7 linked publications.
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 24 Aug 2016.