Perioperative Volume ReplacementPhase 4NCT06663254

Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery

A Phase 4 study testing Hydroxyethyl starch 130/0.4 and Sodium acetate Ringer in people with Perioperative Volume Replacement and Hydroxyethyl Starch, run by Xiangya Hospital of Central South University at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The investigators propose a multicenter randomized trial to test the renal safety of 6% hydroxyethyl starch (HES) 130/0.4 combined with sodium acetate Ringer's crystalloid solution in moderate-to-high cardiovascular risk patients having major abdominal surgery. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Perioperative Volume Replacement, Hydroxyethyl Starch
What is being tested?: Hydroxyethyl starch 130/0.4 and Sodium acetate Ringer
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 410 participants
Where: 6 sitesChina
Study dates: 30 Nov 2024to 30 Aug 2026
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are at least 45 years old;
Scheduled for elective open or laparoscopic gastrointestinal surgery expected to last ≥2 hours;
Having general anesthesia;
Expected to require at least overnight hospitalization;
Subject to at least one of the following risk factors:
Age ≥65 years;

Show all 14Show fewer

History of peripheral arterial disease;
History of coronary artery disease;
History of stroke or transient ischemic attack;
Diabetes requiring medication;
Current smoking or 15-pack-year history of smoking tobacco;
Body mass index ≥30 kg/m2;
Preoperative high-sensitivity troponin T ≥14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay), or 25% of the 99% percentile for other assays - all within 6 months;
B-type natriuretic protein (BNP) ≥80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) ≥200 ng/L within six months.

Who cannot join

Participate in conflicting studies;
Are designated American Society of Anesthesiologists physical status 4;
Are pregnant and/or breastfeeding;
Have hypoproteinemia (serum albumin <30 g/L) or were given preoperative intravenous colloids, including albumin;
Have recent intracranial or cerebral hemorrhage;
Have preoperative acute kidney injury or chronic renal insufficiency (Serum Creatine ≥140 µmol/L for men, Serum Creatine≥120 µmol/L for women and/or oliguria/anuria) or renal replacement therapy;

Show all 16Show fewer

Have severe hepatic impairment (Alanine Transaminase (ALT) and/or Aspartate Aminotransferase (AST) more than two times the upper limit of normal);
Are in congestive heart failure or have pulmonary edema;
Are critically ill or septic;
Have electrolyte disorders such as hypernatremia, hyperchloremia, hyperkalemia, or severe alkalosis;
Are fluid overloaded or dehydrated;
Have clinically meaningful coagulation or bleeding disorders;
Had a solid organ transplant;
Have a current serious burn injury;
Have a mental illness that precludes adequate consent or cooperation with the proposed trial;
Have known hypersensitivity or contraindication to Volulyte 6% or any sodium acetate Ringer solution component.

Trial locations and contacts

6 sites in 1 country.

E Wang, M.D., Ph.D. contact

+8618874889950

ewang324@csu.edu.cn

City, postcode or hospital

6 sites in 1 country

China6 sites

Chaoyang Hospital of Capital Medical University
Beijing
Director, Department of Anesthesiology, +86-010-85231777
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
E Wang, M.D., Ph.D., +86-0731-84327413, ewang324@csu.edu.cn
E Wang
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
Director, Department of Anesthesiology, +86-0531-89268763
The First Hospital of China Medical University
Shenyang, Liaoning
Director, Department of Anesthesiology, +86-024-961200
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi
Director, Department of Anesthesiology, +86-029-85323112
The First Affiliated Hospital of Zhengzhou University;
Zhengzhou, Henan
Director, Department of Anesthesiology, +86-0371-67966266

Other trials in China

About this study

Official title: Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery: a Parallel-group, Double-blind Randomized Trial

Read the detailed description

The investigators will test the primary hypothesis that the maximum decrease in serum Cystatin-C-based estimated glomerular filtration rate (eGFR) from preoperatively through the initial 3 postoperative hospital days is non-inferior in patients who are randomized to a goal-directed combination of HES and crystalloid volume replacement versus goal-directed crystalloid alone.

Secondarily, the investigators will determine the long-term renal safety (cystatin C-based eGFR on postoperative 1 and 3 months) of HES and its effect on major adverse cardiovascular events and the length of hospitalization. Exploratory outcomes will include intraoperative hemodynamic indices, postoperative gastrointestinal indicators, the rate of unscheduled transferring to intensive care unit, the incidence of hospital re-admission within 30 days, the incidence of renal replacement therapy within 90 days after surgery, and the incidence of acute kidney injury based on serum creatine within 7 days.

Conditions: Perioperative Volume Replacement, Hydroxyethyl Starch
Being tested: Hydroxyethyl starch 130/0.4, Sodium acetate Ringer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydroxyethyl starch 130/0.4Drug
Also called Volulyte 6%, 6% Hydroxyethyl starch 130/0.4
Individualized goal-directed administration of 6% Hydroxyethyl starch (HES) 130/0.4: After the induction of anesthesia, 200 ml trial fluid will be infused over 20 min. If stroke volume (SV) increases \>10%, another 200 ml fluid will be given. After that, the use of trial fluid will be determined by the patients' Stroke Volume Variation (SVV). If the SVV exceeds 12%, 200 ml trial fluid will be given over 20 min; this will be repeated until SVV \<12%. If the use of HES exceeds 30 ml/kg, sodium acetate Ringer will be replaced. In addition, patients will have a background infusion of sodium acetate Ringer's solution at 4 ml/kg/h to satisfy the maintenance fluid requirements during surgery.
Sodium acetate RingerDrug
Individualized goal-directed administration of crystalloid alone: After the induction of anesthesia, 200 ml trial fluid will be infused over 20 min.
If stroke volume (SV) increases \>10%, another 200 ml fluid will be given. After that, the use of trial fluid will be determined by the patients' Stroke Volume Variation (SVV). If the SVV exceeds 12%, 200 ml trial fluid will be given over 20 min; this will be repeated until SVV \<12%. In addition, patients will have a background infusion of sodium acetate, the maintenance fluid requirement during surgery.

Study groups in NCT06663254
Study group	Role	What they receive
6% hydroxyethyl starch 130/0.4	Experimental	Not described Receives: Drug: Hydroxyethyl starch 130/0.4
Sodium acetate Ringer	Other	Not described Receives: Drug: Sodium acetate Ringer

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum change in serum Cystatin-C based estimated glomerular filtration rate (eGFR) from baseline through initial 3 postoperative hospital days
The decrease in cystatin-C-based eGFR from preoperatively to the minimum value recorded during the initial three postoperative hospital days. Increases in postoperative eGFR will be considered a reduction of 0 for analysis purposes.
Measured: Baseline and postoperative 1/2/3 day

Secondary outcomes (4)

Cystatin-C based eGFR on postoperative 1 month
The absolute value of cystatin-C based eGFR on postoperative 1 month.
Measured: Postoperative 1 month
Cystatin-C based eGFR on postoperative 3 months
The absolute value of cystatin-C based eGFR on postoperative 3 months.
Measured: Postoperative 3 months
Postoperative major adverse cardiovascular events composite
Major adverse cardiovascular events are a composite of all-cause mortality or one or more of the following cardiovascular complications occurring within 30 days after surgery: myocardial injury after non-cardiac surgery (MINS), non-fatal cardiac arrest, stroke, ventricular arrhythmia requiring treatment.
Measured: Postoperative 30 days
The length of hospitalization
Measured: Postoperative 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202430 Aug 2026

First posted29 Oct 2024
Study start30 Nov 2024 (estimated)
Primary completion30 Mar 2026 (estimated)
Study completion30 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Perioperative Volume ReplacementStudies of the same condition, open and under way.
More trials run by Xiangya Hospital of Central South UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 410 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06663254
Sponsor's protocol ID: XiangyaHMZKHES
Other IDs: 2024060725
Status last verified: Sep 2024
First submitted: 5 Sep 2024
Last updated: 29 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

Reiterer C, Kabon B, Taschner A, Zotti O, Kurz A, Fleischmann E. A comparison of intraoperative goal-directed intravenous administration of crystalloid versus colloid solutions on the postoperative maximum N-terminal pro brain natriuretic peptide in patients undergoing moderate- to high-risk noncardiac surgery. BMC Anesthesiol. 2020 Aug 4;20(1):192. doi: 10.1186/s12871-020-01104-9.
PubMed 32753064
Yates DR, Davies SJ, Milner HE, Wilson RJ. Crystalloid or colloid for goal-directed fluid therapy in colorectal surgery. Br J Anaesth. 2014 Feb;112(2):281-9. doi: 10.1093/bja/aet307. Epub 2013 Sep 20.
PubMed 24056586
Futier E, Garot M, Godet T, Biais M, Verzilli D, Ouattara A, Huet O, Lescot T, Lebuffe G, Dewitte A, Cadic A, Restoux A, Asehnoune K, Paugam-Burtz C, Cuvillon P, Faucher M, Vaisse C, El Amine Y, Beloeil H, Leone M, Noll E, Piriou V, Lasocki S, Bazin JE, Pereira B, Jaber S; FLASH Trial Group; Lasocki S, Huet O, Cadic A, Jacob C, Paugam-Burtz C, Restoux A, Ouattara A, Feitita I, Deloge E, Defaye M, Joannes-Boyau O, Carles P, Napolitano G, Monziols S, Futier E, Vignaud M, Paul S, Gahbiche K, Fayon J, Laroche E, Bazin JE, Brandely A, Le Moal C, Lebuffe G, Garot M, Piriou V, Jaber S, Chanques G, Verzilli D, De Jong A, Millot A, Castagnoli A, Leone M, Pastene B, Castelli C, Medam S, Velly L, Vaisse C, Faucher M, Asehnoune K, Samba E, Roquilly A, Le Penndu M, Cuvillon P, Yves Lefrant J, Wira O, Dubout E, Mfam WS, Lescot T, Begneu E, Burey J, Cirilovic T, Beloeil H, Allo G, Pottecher J, Lebas B, Venot C, Rameau JP, Dimache F, Leger PS, El Amine Y. Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):225-236. doi: 10.1001/jama.2019.20833.
PubMed 31961418
Kabon B, Sessler DI, Kurz A; Crystalloid-Colloid Study Team. Effect of Intraoperative Goal-directed Balanced Crystalloid versus Colloid Administration on Major Postoperative Morbidity: A Randomized Trial. Anesthesiology. 2019 May;130(5):728-744. doi: 10.1097/ALN.0000000000002601.
PubMed 30882476
Joosten A, Delaporte A, Ickx B, Touihri K, Stany I, Barvais L, Van Obbergh L, Loi P, Rinehart J, Cannesson M, Van der Linden P. Crystalloid versus Colloid for Intraoperative Goal-directed Fluid Therapy Using a Closed-loop System: A Randomized, Double-blinded, Controlled Trial in Major Abdominal Surgery. Anesthesiology. 2018 Jan;128(1):55-66. doi: 10.1097/ALN.0000000000001936.
PubMed 29068831
Reiterer C, Kabon B, Halvorson S, Sessler DI, Mascha EJ, Kurz A; Crystalloid-Colloid Research Group. Hemodynamic Responses to Crystalloid and Colloid Fluid Boluses during Noncardiac Surgery. Anesthesiology. 2022 Jan 1;136(1):127-137. doi: 10.1097/ALN.0000000000004040.
PubMed 34724045
Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3.
PubMed 29576114
Ruetzler K, Khanna AK, Sessler DI. Myocardial Injury After Noncardiac Surgery: Preoperative, Intraoperative, and Postoperative Aspects, Implications, and Directions. Anesth Analg. 2020 Jul;131(1):173-186. doi: 10.1213/ANE.0000000000004567.
PubMed 31880630
Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and Management of Patients With Myocardial Injury After Noncardiac Surgery: A Scientific Statement From the American Heart Association. Circulation. 2021 Nov 9;144(19):e287-e305. doi: 10.1161/CIR.0000000000001024. Epub 2021 Oct 4.
PubMed 34601955
Xu Y, Wang S, He L, Yu H, Yu H. Hydroxyethyl starch 130/0.4 for volume replacement therapy in surgical patients: a systematic review and meta-analysis of randomized controlled trials. Perioper Med (Lond). 2021 May 11;10(1):16. doi: 10.1186/s13741-021-00182-8.
PubMed 33971968
Chappell D, van der Linden P, Ripolles-Melchor J, James MFM. Safety and efficacy of tetrastarches in surgery and trauma: a systematic review and meta-analysis of randomised controlled trials. Br J Anaesth. 2021 Oct;127(4):556-568. doi: 10.1016/j.bja.2021.06.040. Epub 2021 Jul 28.
PubMed 34330414

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery: a Parallel-group, Double-blind Randomized Trial
ClinicalTrials.gov ID: NCT06663254
Acronym / sponsor ID: XiangyaHMZKHES
Conditions: Perioperative Volume Replacement, Hydroxyethyl Starch
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 410 participants (estimated)
Lead sponsor: Xiangya Hospital of Central South UniversityUniversity, hospital or other
Study start: 30 Nov 2024 (estimated)
Primary completion: 30 Mar 2026 (estimated)
Study completion: 30 Aug 2026 (estimated)
First posted: 29 Oct 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
6% hydroxyethyl starch 130/0.4	Experimental	Drug: Hydroxyethyl starch 130/0.4
Sodium acetate Ringer	Other	Drug: Sodium acetate Ringer

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Are at least 45 years old;
Scheduled for elective open or laparoscopic gastrointestinal surgery expected to last ≥2 hours;
Having general anesthesia;
Expected to require at least overnight hospitalization;
Subject to at least one of the following risk factors:

Key exclusion criteria (16 listed)

Participate in conflicting studies;
Are designated American Society of Anesthesiologists physical status 4;
Are pregnant and/or breastfeeding;
Have hypoproteinemia (serum albumin <30 g/L) or were given preoperative intravenous colloids, including albumin;
Have recent intracranial or cerebral hemorrhage;

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
Hydroxyethyl starch 130/0.4Also: Volulyte 6%, 6% Hydroxyethyl starch 130/0.4Individualized goal-directed administration of 6% Hydroxyethyl starch (HES) 130/0.4: After the induction of anesthesia, 200 ml trial fluid will be infused over 20 min. If stroke volume (SV) increases \>10%, another 200 ml fluid will be given. After that, the use of trial fluid will be determined by the patients' Stroke Volume Variation (SVV). If the SVV exceeds 12%, 200 ml trial fluid will be given over 20 min; this will be repeated until SVV \<12%. If the use of HES exceeds 30 ml/kg, sodium acetate Ringer will be replaced. In addition, patients will have a background infusion of sodium acetate Ringer's solution at 4 ml/kg/h to satisfy the maintenance fluid requirements during surgery.	Drug	6% hydroxyethyl starch 130/0.4
Sodium acetate RingerIndividualized goal-directed administration of crystalloid alone: After the induction of anesthesia, 200 ml trial fluid will be infused over 20 min. If stroke volume (SV) increases \>10%, another 200 ml fluid will be given. After that, the use of trial fluid will be determined by the patients' Stroke Volume Variation (SVV). If the SVV exceeds 12%, 200 ml trial fluid will be given over 20 min; this will be repeated until SVV \<12%. In addition, patients will have a background infusion of sodium acetate, the maintenance fluid requirement during surgery.	Drug	Sodium acetate Ringer

Primary outcome

Maximum change in serum Cystatin-C based estimated glomerular filtration rate (eGFR) from baseline through initial 3 postoperative hospital days
Time frame: Baseline and postoperative 1/2/3 day
The decrease in cystatin-C-based eGFR from preoperatively to the minimum value recorded during the initial three postoperative hospital days. Increases in postoperative eGFR will be considered a reduction of 0 for analysis purposes.

4 secondary outcomes

Cystatin-C based eGFR on postoperative 1 month
Time frame: Postoperative 1 month
Cystatin-C based eGFR on postoperative 3 months
Time frame: Postoperative 3 months
Postoperative major adverse cardiovascular events composite
Time frame: Postoperative 30 days
The length of hospitalization
Time frame: Postoperative 3 month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
Background: PubMed 32753064Reiterer C, Kabon B, Taschner A, Zotti O, Kurz A, Fleischmann E. A comparison of intraoperative goal-directed intravenous administration of crystalloid versus colloid solutions on the postoperative maximum N-terminal pro brain natriuretic peptide in patients undergoing moderate- to high-risk noncardiac surgery. BMC Anesthesiol. 2020 Aug 4;20(1):192. doi: 10.1186/s12871-020-01104-9.
Background: PubMed 24056586Yates DR, Davies SJ, Milner HE, Wilson RJ. Crystalloid or colloid for goal-directed fluid therapy in colorectal surgery. Br J Anaesth. 2014 Feb;112(2):281-9. doi: 10.1093/bja/aet307. Epub 2013 Sep 20.
Background: PubMed 31961418Futier E, Garot M, Godet T, Biais M, Verzilli D, Ouattara A, Huet O, Lescot T, Lebuffe G, Dewitte A, Cadic A, Restoux A, Asehnoune K, Paugam-Burtz C, Cuvillon P, Faucher M, Vaisse C, El Amine Y, Beloeil H, Leone M, Noll E, Piriou V, Lasocki S, Bazin JE, Pereira B, Jaber S; FLASH Trial Group; Lasocki S, Huet O, Cadic A, Jacob C, Paugam-Burtz C, Restoux A, Ouattara A, Feitita I, Deloge E, Defaye M, Joannes-Boyau O, Carles P, Napolitano G, Monziols S, Futier E, Vignaud M, Paul S, Gahbiche K, Fayon J, Laroche E, Bazin JE, Brandely A, Le Moal C, Lebuffe G, Garot M, Piriou V, Jaber S, Chanques G, Verzilli D, De Jong A, Millot A, Castagnoli A, Leone M, Pastene B, Castelli C, Medam S, Velly L, Vaisse C, Faucher M, Asehnoune K, Samba E, Roquilly A, Le Penndu M, Cuvillon P, Yves Lefrant J, Wira O, Dubout E, Mfam WS, Lescot T, Begneu E, Burey J, Cirilovic T, Beloeil H, Allo G, Pottecher J, Lebas B, Venot C, Rameau JP, Dimache F, Leger PS, El Amine Y. Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):225-236. doi: 10.1001/jama.2019.20833.
Background: PubMed 30882476Kabon B, Sessler DI, Kurz A; Crystalloid-Colloid Study Team. Effect of Intraoperative Goal-directed Balanced Crystalloid versus Colloid Administration on Major Postoperative Morbidity: A Randomized Trial. Anesthesiology. 2019 May;130(5):728-744. doi: 10.1097/ALN.0000000000002601.
Background: PubMed 29068831Joosten A, Delaporte A, Ickx B, Touihri K, Stany I, Barvais L, Van Obbergh L, Loi P, Rinehart J, Cannesson M, Van der Linden P. Crystalloid versus Colloid for Intraoperative Goal-directed Fluid Therapy Using a Closed-loop System: A Randomized, Double-blinded, Controlled Trial in Major Abdominal Surgery. Anesthesiology. 2018 Jan;128(1):55-66. doi: 10.1097/ALN.0000000000001936.
Background: PubMed 34724045Reiterer C, Kabon B, Halvorson S, Sessler DI, Mascha EJ, Kurz A; Crystalloid-Colloid Research Group. Hemodynamic Responses to Crystalloid and Colloid Fluid Boluses during Noncardiac Surgery. Anesthesiology. 2022 Jan 1;136(1):127-137. doi: 10.1097/ALN.0000000000004040.
Background: PubMed 29576114Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3.
Background: PubMed 31880630Ruetzler K, Khanna AK, Sessler DI. Myocardial Injury After Noncardiac Surgery: Preoperative, Intraoperative, and Postoperative Aspects, Implications, and Directions. Anesth Analg. 2020 Jul;131(1):173-186. doi: 10.1213/ANE.0000000000004567.
Background: PubMed 34601955Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and Management of Patients With Myocardial Injury After Noncardiac Surgery: A Scientific Statement From the American Heart Association. Circulation. 2021 Nov 9;144(19):e287-e305. doi: 10.1161/CIR.0000000000001024. Epub 2021 Oct 4.
Background: PubMed 33971968Xu Y, Wang S, He L, Yu H, Yu H. Hydroxyethyl starch 130/0.4 for volume replacement therapy in surgical patients: a systematic review and meta-analysis of randomized controlled trials. Perioper Med (Lond). 2021 May 11;10(1):16. doi: 10.1186/s13741-021-00182-8.
Background: PubMed 34330414Chappell D, van der Linden P, Ripolles-Melchor J, James MFM. Safety and efficacy of tetrastarches in surgery and trauma: a systematic review and meta-analysis of randomised controlled trials. Br J Anaesth. 2021 Oct;127(4):556-568. doi: 10.1016/j.bja.2021.06.040. Epub 2021 Jul 28.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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.

E Wang, M.D., Ph.D. contact

+8618874889950

ewang324@csu.edu.cn

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact E Wang, M.D., Ph.D. (+8618874889950, ewang324@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum change in serum Cystatin-C based estimated glomerular filtration rate (eGFR) from baseline through initial 3 postoperative hospital days (time frame: Baseline and postoperative 1/2/3 day). 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 NCT06663254, which also lists 11 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 29 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.