Coronary Artery Bypass, Off-PumpNCT03629418
Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery
A study testing Targeted blood-pressure management and Routine blood-pressure management in people with Coronary Artery Bypass, Off-Pump and Intraoperative Hypotension, run by Peking University First Hospital at 1 site in China.
Trial summary
Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. It is now realized that intraoperative hypotension is an important risk factor for the development of AKI. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury
- What is being tested?
- Targeted blood-pressure management and Routine blood-pressure management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2018to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years;
- Scheduled to undergo off-pump CABG surgery.
Who cannot join
- Refuse to participate;
- Untreated or uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
- Chronic kidney disease with a glomerular filtration rate < 30 ml/min/1.73 m2 or end-stage renal disease requiring renal-replacement therapy;
- Inability to communicate during the preoperative period because of coma, profound dementia, language barrier, or end-stage disease;
- Requirement of vasopressors/inotropics to maintain blood pressure before surgery;
- Second or emergency surgery;
- Expected survival of less than 24 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing University First Hospital
Beijing, Beijing Municipality, 100034
Dong-Xin Wang, MD, PHD, 8610-83572784, wangdongxin@hotmail.com
Li Huang, MD, PhD, 8610-83572460, huanglibd@163.com
About this study
Official title: Impact of Targeted Blood-pressure Management on Incidence of Acute Kidney Injury After Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial
Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. It is now realized that intraoperative hypotension is an important risk factor for the development of AKI. In a recent randomized controlled trial of patients undergoing major noncardiac surgery, intraoperative individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. The investigators hypothesize that, for patients undergoing off-pump CABG, targeted blood-pressure management during surgery may also reduce the incidence of postoperative AKI.
Read the detailed description
Acute renal injury (AKI) is a common complication after cardiac surgery. In patients undergoing noncardiac surgery, intraoperative hypotension may lead to hypoperfusion of important organs and result in organ injuries such as AKI, myocardial injury, and stroke. The development of organ injuries is associated with wose outcomes including higher 30-day or even 1-year mortality. In a recent randomized controlled trial, patients undergoing major noncardiac surgery received either individualized (systolic blood pressure [SBP] maintained within 10% of the reference level) or standard (SBP maintained above 80 mmHg or within 40% of the reference level) blood-pressure management strategy during surgery. The results showed that individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. Intraoperative hypotension is very common during off-pump coronary artery bypass grafting (CABG) surgery. The investigators hypothesize that, for patients undergoing off-pump CABG, good blood-pressure management with norepinephrine may also reduce the incidence of postoperative AKI. The purpose of this study is to investigate the effect of targeted blood-pressure management during off-pump CABG surgery on the incidence of postoperative AKI.
- Conditions
- Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care
- Being tested
- Targeted blood-pressure management, Routine blood-pressure management
- Keywords
- Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted blood-pressure managementDrug
Also called Norepinephrine
Prophylactic norepinephrine infusion is started before anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher.
Routine blood-pressure managementDrug
Also called Phenylephrine and other vasopressors
Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Targeted blood-pressure management | Experimental | Prophylactic norepinephrine infusion is started at the beginning of anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher during surgery. Receives: Drug: Targeted blood-pressure management |
| Routine blood-pressure management | Active comparator | Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery. Receives: Drug: Routine blood-pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury (AKI) within 7 days after surgery
Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria
Measured: Up to 7 days after surgery
Secondary outcomes (12)
Classification of AKI within 7 days after surgery
Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria
Measured: Up to 7 days after surgery
Incidence of delirium within 7 days after surgery
Development of delirium within 7 days after surgery is assessed with the Confusion Assessment Method (3D-CAM for patients without mechanical ventilation and CAM-ICU for patients with mechanical ventilation).
Measured: Up to 7 days after surgery
Duration of mechanical ventilation after surgery
Duration of mechanical ventilation after surgery
Measured: Up to 30 days after surgery
Length of stay in intensive care unit (ICU) after surgery
Length of stay in intensive care unit (ICU) after surgery
Measured: Up to 30 days after surgery
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Measured: Up to 30 days after surgery
Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery
MACEs within 30 days after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.
Measured: Up to 30 days after surgery
Incidence of non-MACE complications within 30 days after surgery
Non-MACE complications within 30 days after surgery indicate new-onset medical conditions other than MACEs that produce harmful effects on patients' recovery and required therapeutic intervention.
Measured: Up to 30 days after surgery
All-cause 30-day mortality
All-cause 30-day mortality
Measured: At 30 days after surgery
2-year overall survival after surgery
2-year overall survival after surgery
Measured: Up to 2 years after surgery
2-year major adverse cardiovascular event (MACE)-free survival after surgery
MACEs within 2 years after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.
Measured: Up to 2 years after surgery
Cognitive function in 1- and 2-year survivors
Cognitive function in 1- and 2-year survivors is assessed with the modified Telephone Interview for Cognitive Status (TICS-m, score ranges from 0 to 40, with higher score indicating better function).
Measured: At the end of the 1st and 2nd years after surgery
Quality of life in 1- and 2- year survivors: SF-36
Quality of life in 1- and 2-year survivors is assessed with the 36-Item Short Form Health Survey (SF-36). The SF-36 evaluates 8 different domains of quality of life, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The score of each domain ranges from 0 to 100, with high score indicating better function.
Measured: At the end of the 1st and 2nd years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start14 Aug 2018
- Primary completionDec 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass, Off-PumpStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629418
- Sponsor's protocol ID
- 2018-118
- Status last verified
- Jul 2025
- First submitted
- 9 Aug 2018
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abelha FJ, Botelho M, Fernandes V, Barros H. Determinants of postoperative acute kidney injury. Crit Care. 2009;13(3):R79. doi: 10.1186/cc7894. Epub 2009 May 22.
PubMed 19463152Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
PubMed 19934864Coca SG, Peixoto AJ, Garg AX, Krumholz HM, Parikh CR. The prognostic importance of a small acute decrement in kidney function in hospitalized patients: a systematic review and meta-analysis. Am J Kidney Dis. 2007 Nov;50(5):712-20. doi: 10.1053/j.ajkd.2007.07.018.
PubMed 17954284Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
PubMed 15616043Schopka S, Diez C, Camboni D, Floerchinger B, Schmid C, Hilker M. Impact of cardiopulmonary bypass on acute kidney injury following coronary artery bypass grafting: a matched pair analysis. J Cardiothorac Surg. 2014 Jan 18;9:20. doi: 10.1186/1749-8090-9-20.
PubMed 24438155Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. doi: 10.2215/CJN.00240605. Epub 2005 Oct 19.
PubMed 17699187Kheterpal S, Tremper KK, Heung M, Rosenberg AL, Englesbe M, Shanks AM, Campbell DA Jr. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009 Mar;110(3):505-15. doi: 10.1097/ALN.0b013e3181979440.
PubMed 19212261Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320.
PubMed 22277949Rettig TCD, Peelen LM, Geuzebroek GSC, van Klei WA, Boer C, van der Veer JW, Hofland J, van de Garde EMW, Noordzij PG. Impact of Intraoperative Hypotension During Cardiopulmonary Bypass on Acute Kidney Injury After Coronary Artery Bypass Grafting. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):522-528. doi: 10.1053/j.jvca.2016.07.040. Epub 2016 Jul 30.
PubMed 27727080Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
PubMed 10439777Hiltebrand LB, Koepfli E, Kimberger O, Sigurdsson GH, Brandt S. Hypotension during fluid-restricted abdominal surgery: effects of norepinephrine treatment on regional and microcirculatory blood flow in the intestinal tract. Anesthesiology. 2011 Mar;114(3):557-64. doi: 10.1097/ALN.0b013e31820bfc81.
PubMed 21307765Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
PubMed 28973220Boettger S, Nunez DG, Meyer R, Richter A, Fernandez SF, Rudiger A, Schubert M, Jenewein J. Delirium in the intensive care setting and the Richmond Agitation and Sedation Scale (RASS): Drowsiness increases the risk and is subthreshold for delirium. J Psychosom Res. 2017 Dec;103:133-139. doi: 10.1016/j.jpsychores.2017.09.011. Epub 2017 Oct 4.
PubMed 29167040Chanques G, Garnier O, Carr J, Conseil M, de Jong A, Rowan CM, Ely EW, Jaber S. The CAM-ICU has now a French "official" version. The translation process of the 2014 updated Complete Training Manual of the Confusion Assessment Method for the Intensive Care Unit in French (CAM-ICU.fr). Anaesth Crit Care Pain Med. 2017 Oct;36(5):297-300. doi: 10.1016/j.accpm.2017.02.003. Epub 2017 Mar 29.
PubMed 28365244
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Targeted Blood-pressure Management on Incidence of Acute Kidney Injury After Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03629418
- Acronym / sponsor ID
- 2018-118
- Conditions
- Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care
- Keywords
- Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 14 Aug 2018 (actual)
- 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.
Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. It is now realized that intraoperative hypotension is an important risk factor for the development of AKI. In a recent randomized controlled trial of patients undergoing major noncardiac surgery, intraoperative individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. The investigators hypothesize that, for patients undergoing off-pump CABG, targeted blood-pressure management during surgery may also reduce the incidence of postoperative AKI.
Detailed description
Acute renal injury (AKI) is a common complication after cardiac surgery. In patients undergoing noncardiac surgery, intraoperative hypotension may lead to hypoperfusion of important organs and result in organ injuries such as AKI, myocardial injury, and stroke. The development of organ injuries is associated with wose outcomes including higher 30-day or even 1-year mortality. In a recent randomized controlled trial, patients undergoing major noncardiac surgery received either individualized (systolic blood pressure [SBP] maintained within 10% of the reference level) or standard (SBP maintained above 80 mmHg or within 40% of the reference level) blood-pressure management strategy during surgery. The results showed that individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. Intraoperative hypotension is very common during off-pump coronary artery bypass grafting (CABG) surgery. The investigators hypothesize that, for patients undergoing off-pump CABG, good blood-pressure management with norepinephrine may also reduce the incidence of postoperative AKI. The purpose of this study is to investigate the effect of targeted blood-pressure management during off-pump CABG surgery on the incidence of postoperative AKI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted blood-pressure management | Experimental | Drug: Targeted blood-pressure managementProphylactic norepinephrine infusion is started at the beginning of anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher during surgery. |
| Routine blood-pressure management | Active comparator | Drug: Routine blood-pressure managementPhenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 50 years;
- Scheduled to undergo off-pump CABG surgery.
Key exclusion criteria (7 listed)
- Refuse to participate;
- Untreated or uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
- Chronic kidney disease with a glomerular filtration rate < 30 ml/min/1.73 m2 or end-stage renal disease requiring renal-replacement therapy;
- Inability to communicate during the preoperative period because of coma, profound dementia, language barrier, or end-stage disease;
- Requirement of vasopressors/inotropics to maintain blood pressure before surgery;
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 |
|---|---|---|
| Targeted blood-pressure managementAlso: NorepinephrineProphylactic norepinephrine infusion is started before anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher. | Drug | Targeted blood-pressure management |
| Routine blood-pressure managementAlso: Phenylephrine and other vasopressorsPhenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery. | Drug | Routine blood-pressure management |
Primary outcome
Incidence of acute kidney injury (AKI) within 7 days after surgery
Time frame: Up to 7 days after surgery
Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria
12 secondary outcomes
Classification of AKI within 7 days after surgery
Time frame: Up to 7 days after surgery
Incidence of delirium within 7 days after surgery
Time frame: Up to 7 days after surgery
Duration of mechanical ventilation after surgery
Time frame: Up to 30 days after surgery
Length of stay in intensive care unit (ICU) after surgery
Time frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Time frame: Up to 30 days after surgery
Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery
Time frame: Up to 30 days after surgery
Incidence of non-MACE complications within 30 days after surgery
Time frame: Up to 30 days after surgery
All-cause 30-day mortality
Time frame: At 30 days after surgery
2-year overall survival after surgery
Time frame: Up to 2 years after surgery
2-year major adverse cardiovascular event (MACE)-free survival after surgery
Time frame: Up to 2 years after surgery
Cognitive function in 1- and 2-year survivors
Time frame: At the end of the 1st and 2nd years after surgery
Quality of life in 1- and 2- year survivors: SF-36
Time frame: At the end of the 1st and 2nd years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 19463152Abelha FJ, Botelho M, Fernandes V, Barros H. Determinants of postoperative acute kidney injury. Crit Care. 2009;13(3):R79. doi: 10.1186/cc7894. Epub 2009 May 22.
- Background: PubMed 19934864Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
- Background: PubMed 17954284Coca SG, Peixoto AJ, Garg AX, Krumholz HM, Parikh CR. The prognostic importance of a small acute decrement in kidney function in hospitalized patients: a systematic review and meta-analysis. Am J Kidney Dis. 2007 Nov;50(5):712-20. doi: 10.1053/j.ajkd.2007.07.018.
- Background: PubMed 15616043Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
- Background: PubMed 24438155Schopka S, Diez C, Camboni D, Floerchinger B, Schmid C, Hilker M. Impact of cardiopulmonary bypass on acute kidney injury following coronary artery bypass grafting: a matched pair analysis. J Cardiothorac Surg. 2014 Jan 18;9:20. doi: 10.1186/1749-8090-9-20.
- Background: PubMed 17699187Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. doi: 10.2215/CJN.00240605. Epub 2005 Oct 19.
- Background: PubMed 19212261Kheterpal S, Tremper KK, Heung M, Rosenberg AL, Englesbe M, Shanks AM, Campbell DA Jr. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009 Mar;110(3):505-15. doi: 10.1097/ALN.0b013e3181979440.
- Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Background: PubMed 22277949Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320.
- Background: PubMed 27727080Rettig TCD, Peelen LM, Geuzebroek GSC, van Klei WA, Boer C, van der Veer JW, Hofland J, van de Garde EMW, Noordzij PG. Impact of Intraoperative Hypotension During Cardiopulmonary Bypass on Acute Kidney Injury After Coronary Artery Bypass Grafting. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):522-528. doi: 10.1053/j.jvca.2016.07.040. Epub 2016 Jul 30.
- Background: PubMed 10439777Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
- Background: PubMed 21307765Hiltebrand LB, Koepfli E, Kimberger O, Sigurdsson GH, Brandt S. Hypotension during fluid-restricted abdominal surgery: effects of norepinephrine treatment on regional and microcirculatory blood flow in the intestinal tract. Anesthesiology. 2011 Mar;114(3):557-64. doi: 10.1097/ALN.0b013e31820bfc81.
- Individual participant dataSharing planned: No
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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.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted blood-pressure management and Routine blood-pressure management in people with Coronary Artery Bypass, Off-Pump and Intraoperative Hypotension, run by Peking University First Hospital at 1 site in China.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Xin Wang, MD, PhD (8610-83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury (AKI) within 7 days after surgery (time frame: Up to 7 days after surgery). 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 NCT03629418, which also lists 16 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 30 Jul 2025.