| Condition or disease |
|---|
| Thoracic Surgery Acute Kidney Injury Critical Care |
Acute renal failure (ARF) and the need for renal replacement therapy (RRT) is a major complication after cardiac surgery, associated with mortality and an increased risk to develop end-stage renal disease. Cardiac surgery patients are at increased risk to develop acute kidney failure due to ischaemia-reperfusion injury, cardiopulmonary bypass (CPB) induced inflammation and haemolysis, hemodynamic alterations, vasoconstriction and resulting reduced renal perfusion. According to the current literature, AKI occurs in average in 20-30% after cardiac surgery with an incidence of RRT in 1-5%. Several reviews revealed the literature and concluded that , inter alia, euvolemia, adequate nutrition, the avoidance of nephrotoxic drugs and anemia optimization belong to the most effective prevention strategies.
Patients are instructed to follow the nil per os (NPO) guidelines, including abstinence of clear liquids for >2 hours preoperative as well as fasting time of light foods for > 6 hours and fatty foods for >8 hours prior to surgery. However, these guidelines encourage patients to continue PO hydration until 2 h before surgery in order to optimize the volume status. Besides the fact that NPO lasts in average critically longer than required, surgery delay is a common issue and may lead to an exceedance of NPO up to twice as long as required.
Data about the exact mechanism is still sparse, but preoperative iv hydration may correct or even expand intravascular volume, improve renal perfusion and induce diuresis, stimulate endogenous natriuretic peptides release and inactivate the renin-angiotensin-aldosterone system (RAAS).
Large trials on this very relevant topic in these high risk cardiac surgery patients are absolutely missing. Therefore, this prospective observational study aims to investigate the influence of varied preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI.
| Study Type : | Observational |
| Estimated Enrollment : | 320 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury in Cardiac Surgery Patients: the HYDRATE-CSX Trial |
| Actual Study Start Date : | April 23, 2019 |
| Estimated Primary Completion Date : | January 15, 2020 |
| Estimated Study Completion Date : | March 15, 2020 |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Julia Krieger | +49 241 88726 | jukrieger@ukaachen.de |
| Germany | |
| University Hospital RWTH Aachen | Recruiting |
| Aachen, NRW, Germany, 52074 | |
| Contact: Julia Krieger +4924180 ext 88726 jukrieger@ukaachen.de | |
| Principal Investigator: | Julia Ney, Dr. med. | RWTH Aachen University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 2, 2019 | ||||
| First Posted Date | May 6, 2019 | ||||
| Last Update Posted Date | September 11, 2019 | ||||
| Actual Study Start Date | April 23, 2019 | ||||
| Estimated Primary Completion Date | January 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury | ||||
| Official Title | Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury in Cardiac Surgery Patients: the HYDRATE-CSX Trial | ||||
| Brief Summary | To investigate the influence of preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI. | ||||
| Detailed Description |
Acute renal failure (ARF) and the need for renal replacement therapy (RRT) is a major complication after cardiac surgery, associated with mortality and an increased risk to develop end-stage renal disease. Cardiac surgery patients are at increased risk to develop acute kidney failure due to ischaemia-reperfusion injury, cardiopulmonary bypass (CPB) induced inflammation and haemolysis, hemodynamic alterations, vasoconstriction and resulting reduced renal perfusion. According to the current literature, AKI occurs in average in 20-30% after cardiac surgery with an incidence of RRT in 1-5%. Several reviews revealed the literature and concluded that , inter alia, euvolemia, adequate nutrition, the avoidance of nephrotoxic drugs and anemia optimization belong to the most effective prevention strategies. Patients are instructed to follow the nil per os (NPO) guidelines, including abstinence of clear liquids for >2 hours preoperative as well as fasting time of light foods for > 6 hours and fatty foods for >8 hours prior to surgery. However, these guidelines encourage patients to continue PO hydration until 2 h before surgery in order to optimize the volume status. Besides the fact that NPO lasts in average critically longer than required, surgery delay is a common issue and may lead to an exceedance of NPO up to twice as long as required. Data about the exact mechanism is still sparse, but preoperative iv hydration may correct or even expand intravascular volume, improve renal perfusion and induce diuresis, stimulate endogenous natriuretic peptides release and inactivate the renin-angiotensin-aldosterone system (RAAS). Large trials on this very relevant topic in these high risk cardiac surgery patients are absolutely missing. Therefore, this prospective observational study aims to investigate the influence of varied preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients undergoing elective cardiac surgery at the University Hospital RWTH Aachen | ||||
| Condition |
|
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
320 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | March 15, 2020 | ||||
| Estimated Primary Completion Date | January 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03938181 | ||||
| Other Study ID Numbers | 3CARE_BOÄ_18-004_Hydrate-CSX | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | RWTH Aachen University | ||||
| Study Sponsor | RWTH Aachen University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | RWTH Aachen University | ||||
| Verification Date | September 2019 | ||||