Hypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trial
<p><strong>Background:</strong></p> Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy. <p><st...
| Auteurs principaux: | , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Langue: | English |
| Publié: |
Lippincott, Williams & Wilkins
2020
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| _version_ | 1826272501837070336 |
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| author | Breau, RH Fergusson, DA Knoll, G McAlpine, K Morash, C Cnossen, S Lavallée, LT Mallick, R Finelli, A Jewett, MAS Leibovich, BC Cook, JA Kapoor, A Pouliot, F Izawa, J Rendon, R Cagiannos, I |
| author_facet | Breau, RH Fergusson, DA Knoll, G McAlpine, K Morash, C Cnossen, S Lavallée, LT Mallick, R Finelli, A Jewett, MAS Leibovich, BC Cook, JA Kapoor, A Pouliot, F Izawa, J Rendon, R Cagiannos, I |
| author_sort | Breau, RH |
| collection | OXFORD |
| description | <p><strong>Background:</strong></p>
Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy.
<p><strong>Methods:</strong></p>
We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (control group) during partial nephrectomy at six academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of 99mTc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10ml/min/1.73m2 at a 5% significance level.
<p><strong>Findings:</strong></p>
Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/min/1.73m2). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1-year after surgery. The change in mGFR 1-year after surgery was -6.6 ml/min/1.73m2 in the hypothermia group and -7.8 mL/min/1.73m2 in the control group (mean difference 1.2 mL/min/1.73m2, 95% CI -3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (-5.8 vs -6.3 mL/min/1.73m2; mean difference 0.5 mL/min/1.73m2, 95% CI -2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life.
<p><strong>Interpretation:</strong></p>
Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function. |
| first_indexed | 2024-03-06T22:13:34Z |
| format | Journal article |
| id | oxford-uuid:52a3eab7-490f-482b-a33d-b29c0e21b61c |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:13:34Z |
| publishDate | 2020 |
| publisher | Lippincott, Williams & Wilkins |
| record_format | dspace |
| spelling | oxford-uuid:52a3eab7-490f-482b-a33d-b29c0e21b61c2022-03-26T16:26:45ZHypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:52a3eab7-490f-482b-a33d-b29c0e21b61cEnglishSymplectic Elements Lippincott, Williams & Wilkins2020Breau, RHFergusson, DAKnoll, GMcAlpine, KMorash, CCnossen, SLavallée, LTMallick, RFinelli, AJewett, MASLeibovich, BCCook, JAKapoor, APouliot, FIzawa, JRendon, RCagiannos, I<p><strong>Background:</strong></p> Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy. <p><strong>Methods:</strong></p> We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (control group) during partial nephrectomy at six academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of 99mTc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10ml/min/1.73m2 at a 5% significance level. <p><strong>Findings:</strong></p> Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/min/1.73m2). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1-year after surgery. The change in mGFR 1-year after surgery was -6.6 ml/min/1.73m2 in the hypothermia group and -7.8 mL/min/1.73m2 in the control group (mean difference 1.2 mL/min/1.73m2, 95% CI -3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (-5.8 vs -6.3 mL/min/1.73m2; mean difference 0.5 mL/min/1.73m2, 95% CI -2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life. <p><strong>Interpretation:</strong></p> Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function. |
| spellingShingle | Breau, RH Fergusson, DA Knoll, G McAlpine, K Morash, C Cnossen, S Lavallée, LT Mallick, R Finelli, A Jewett, MAS Leibovich, BC Cook, JA Kapoor, A Pouliot, F Izawa, J Rendon, R Cagiannos, I Hypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trial |
| title | Hypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trial |
| title_full | Hypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trial |
| title_fullStr | Hypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trial |
| title_full_unstemmed | Hypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trial |
| title_short | Hypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trial |
| title_sort | hypothermia during partial nephrectomy for patients with renal tumors a randomized controlled trial |
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